MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-11 for STRESSVUE 860295 manufactured by Philips Medical Systems.
[119944903]
A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[119944905]
The customer reported arc in the dvd burner which caused an electrical fire. There was no patient/user injury reported.
Patient Sequence No: 1, Text Type: D, B5
[129939666]
The issue was investigated by philips and the returned pcs were evaluated both by philips and hp and the failures appear to be confined to the? Sata? Power connectors and cable. No damage to any other part/component was visible. Because this is not a philips product, philips cannot definitively determine a root cause for this issue. Replacement pcs resolved issue.
Patient Sequence No: 1, Text Type: N, H10
[129939667]
The customer reported arc in the dvd burner which caused an electrical fire. The device was not connected to a patient at the time of the event. There was no patient/user injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2018-07268 |
| MDR Report Key | 7865118 |
| Date Received | 2018-09-11 |
| Date of Report | 2018-08-20 |
| Date Mfgr Received | 2018-08-20 |
| Device Manufacturer Date | 2011-04-08 |
| Date Added to Maude | 2018-09-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT CORNING |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STRESSVUE |
| Generic Name | NA |
| Product Code | DPS |
| Date Received | 2018-09-11 |
| Model Number | 860295 |
| 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 | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-11 |