MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-25 for MP70 INTELLIVUE PATIENT MONITOR M8007A manufactured by Philips Medical Systems.
[187547794]
A philips field service engineer (fse) went to the customer site and observed failing of loudspeaker inop error. The fse determined the device mainboard was faulty on the mp70 and would require replacement. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610816-2020-00103 |
| MDR Report Key | 9876749 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2003-07-31 |
| Date Added to Maude | 2020-03-25 |
| 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 | 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 | 3 |
| Brand Name | MP70 INTELLIVUE PATIENT MONITOR |
| Generic Name | PATIENT MONITOR |
| Product Code | DSI |
| Date Received | 2020-03-25 |
| Model Number | M8007A |
| 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 | 2020-03-25 |