MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-09 for MP5 M8105A (865024) manufactured by Philips Medical Systems.
[107839319]
Patient Sequence No: 1, Text Type: N, H10
[107839320]
The customer reported that "the patient's heart stopped for 8 seconds and the mp5 did not alarm at all". The device was used for monitoring at the time of the alleged malfunction. The heart of the (b)(6) year-old male patient with a weight of (b)(6) kilos stopped beating for 8 seconds and then started beating again without medical intervention. The customer's biomedical engineer stated that the patient was fine after the occurrence. No death or patient injury or harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610816-2018-00112 |
| MDR Report Key | 7498406 |
| Date Received | 2018-05-09 |
| Date of Report | 2018-04-10 |
| Date Mfgr Received | 2018-04-10 |
| Device Manufacturer Date | 2012-07-25 |
| Date Added to Maude | 2018-05-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BETTY HARRIS |
| Manufacturer Street | HEWLETT-PACKARD STR.2 |
| Manufacturer City | BOEBLINGEN 71034 |
| Manufacturer Country | GM |
| Manufacturer Postal | 71034 |
| 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 | 2018-05-09 |
| Model Number | M8105A (865024) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-05-09 |