MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-07 for MP5 M8105A (865024) manufactured by Philips Medical Systems.
[77238852]
A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[77238853]
The customer reported that "on (b)(6) at 3:47 am; bed 662, the patient's spo2 value dropped to 60% (then 69%) but the monitor did not trigger spo2 alarms (visual or audible). " no death or patient /user injury or harm was reported. The device was used for monitoring at the time of the alleged malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610816-2017-00173 |
| MDR Report Key | 6620170 |
| Date Received | 2017-06-07 |
| Date of Report | 2017-05-15 |
| Date Mfgr Received | 2017-05-15 |
| Device Manufacturer Date | 2010-10-25 |
| Date Added to Maude | 2017-06-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MRS. WENDY CHADBOURNE |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MP5 |
| Generic Name | PATIENT MONITOR |
| Product Code | BZQ |
| Date Received | 2017-06-07 |
| Model Number | M8105A (865024) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | HEWLETT-PACKARD STR.2 BOEBLINGEN 71034 GM 71034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-07 |