Cardiovascular · 510(k) · 2008
VISENSIA
OBS MEDICAL. Cleared by FDA on 17 July 2008 under submission K081140, product code MHX (monitor, physiological, patient(with arrhythmia detection or alarms)). What FDA's record says, in FDA's words.
Device record · K081140
- Device. VISENSIADEVICE
- Company. OBS MEDICALCOMPANY
- Decision. 17 July 2008, 510(k), substantially equivalent (traditional review); received 22 April 2008DECISION
- Panel. CardiovascularPANEL
- Product code. MHX, Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)CODE
- Regulation. 21 CFR 870.1025, Class IIREG
- Source. FDA database entrySOURCE
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 could not be read from a public decision document for this submission on the retrieval date (the document is absent, scanned without text, or filed under another number). FDA's database entry is the place to read it.
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 33,126 reports filed against devices carrying product code MHX. 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 · IntelliVue MX40 1.4GHz · Philips Medical Systems · report 1218950-2026-100677
The customer reported the unit had a speaker malfunction error. It is confirmed the unit did not produce any sound at the time of the event. The device was not in use on a patient at the time of event, there was no adverse event reported.
30 September 2026 · Injury · Patient Information Center iX · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-102043
It was reported that the user requested assistance in retrieving logs following the device's failure to alarm for a cardiac arrest. No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.
30 September 2026 · Malfunction · IntelliVue Multi-Measurement Module X3 · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-102060
It was reported that the device was presented with a speaker malfunction error message and there was no sound coming from the device in standalone mode. The device was in clinical use. There was no report of patient or user harm.
30 September 2026 · Malfunction · Tempus Pro, Printer, IBP · Remote Diagnostic Technologies Ltd. · report 3003832357-2026-100556
This report is based on information provided by a Philips Remote Service Engineer, a Bench Engineer and a Technical Engineer and has been investigated by the Philips Complaint Handling Team. Philips received a complaint on the Tempus Pro, while at a Bench Repair Facility indicating that the ECG (Electrocardiography) nut was loose. There was no patient involvement, therefore no health consequences or impact.
30 September 2026 · Injury · uCor Heart Failure and Arrhythmia Management System · ZOLL Manufacturing Corporation · report 3008642652-2026-09502
A US distributor contacted ZOLL to report that the patient developed a skin irritation from the uCor HFAMS Patch. The patient described the area as a red skin irritation with burning and stinging sensation around and under the uCor HFAMS Patch. It was reported that the patient has prior history of skin sensitivity or allergies. There was no alleged device malfunction contributing to the irritation. The patient contacted their physician regarding skin irritation, but there is no indication that […]
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 MHX, in Cardiovascular, or cleared in 2008. 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.