Cardiovascular · 510(k) · 2018
PeraServer and PeraTrend
PeraHealth, Inc.. Cleared by FDA on 1 May 2018 under submission K172959, product code MWI (monitor, physiological, patient (without arrhythmia detection or alarms)). What FDA's record says, in FDA's words.
Device record · K172959
- Device. PeraServer and PeraTrendDEVICE
- Company. PeraHealth, Inc.COMPANY
- Decision. 1 May 2018, 510(k), substantially equivalent (traditional review); received 26 September 2017DECISION
- Panel. CardiovascularPANEL
- Product code. MWI, Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)CODE
- Regulation. 21 CFR 870.2300, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to compute a patient status index. The Rothman Index is a single measure of a patient’s physiologic condition based on the aggregate statistical mortality risk associated with the values of the patient’s vital signs, nursing assessments, and selected lab values. PeraServer is indicated for use wherever there is interest in generating Rothman Index (RI) scores and/or associated configurable warnings. PeraTrend is indicated for use by healthcare providers whenever there is need for displaying and/or trending RI scores and displaying associated configurable warning states as an adjunct to clinical decision support. PeraServer/PeraTrend is intended for the care of patients throughout the hospital setting (e.g., in the emergency department, on the wards, in intensive care units). The Rothman Index score is validated for use with neonatal, pediatric, and adult patients. It is an adjunct-to and is not intended to replace vital signs monitoring and is not intended for use in the Neonatal Intensive Care Unit.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsmeasurement or quantification
- Mentionsadult patients
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 2,174 reports filed against devices carrying product code MWI. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · Rad-97 · Masimo - 15750 Alton Pkwy · report 3019388613-2026-00708
The customer reported that the device has an audio speaker failure and tb-20 intermittent connection issues. There was no patient impact or consequence reported.
29 September 2026 · Malfunction · Rad-97 · Masimo - 15750 Alton Pkwy · report 3019388613-2026-00705
The customer reported that "after power on the device turn off by itself with no alarm or error message". There was no patient impact or consequence reported.
29 September 2026 · Malfunction · Root · Masimo - 15750 Alton Pkwy · report 3019388613-2026-00707
The customer reported that sometimes it has turned off by itself with no message or alarm. There was no patient impact or consequence reported.
28 September 2026 · Malfunction · Rad-97 with NIBP · Masimo - 15750 Alton Pkwy · report 3019388613-2026-00700
The customer reported that the device will not power on most of the time. if it does turn on, it shuts off by itself. There was no patient impact or consequence reported.
28 September 2026 · Injury · Expression MR400 MRI Patient Monitoring System (Model MR400) · Philips North America LLC · report 50914635
Patient underwent MRI scan with use of Phillips Expression MR400 MRI Patient Monitoring System. After the MRI, he was noted to have a left chest wall burn. Plastic Surgery noted a full thickness chest wall burn that later required surgical debridement and split thickness skin grafting. Manufacturer response for MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS), Expression MR400 MRI Patient Monitoring System (Model MR400) (per site reporter).Provided with IFU changes from […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code MWI, in Cardiovascular, from PeraHealth, Inc., or cleared in 2018. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.