MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for PHILIPS HEALTHCARE MONITOR INTELLIVUE MMS M3001A A04 manufactured by Philips Healthcare / Philips Medizin Systems Boeblingen Gmbh.
[175480096]
Philips m3001a a04 mms unable to provide spo2 value, especially on low-perfusion / compromised pts. Malfunction is not limited to one device. Multiple troubleshooting has occurred, and anticipate a software / hardware problem with the a04 configuration. Previous a02 configuration did not have the same malfunction. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092238 |
| MDR Report Key | 9592144 |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-12-24 |
| Date Added to Maude | 2020-01-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS HEALTHCARE MONITOR |
| Generic Name | MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS |
| Product Code | MWI |
| Date Received | 2020-01-14 |
| Model Number | INTELLIVUE MMS |
| Catalog Number | M3001A A04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS HEALTHCARE / PHILIPS MEDIZIN SYSTEMS BOEBLINGEN GMBH |
| Manufacturer Address | BOTHELL WA 9021 US 9021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-14 |