MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-06-22 for PHILIPS TC02 MODULE M1018A manufactured by Philips Medical Systems.
[1343738]
The customer alleged that the tcgas module failed to calibrate properly and failed to provide accurate measurement data.
Patient Sequence No: 1, Text Type: D, B5
[8555871]
The customer alleged that the tcgas module failed to calibrate properly and failed to provide accurate measurement data. The available info does not support that there was any device malfunction or that the use of this device was a factor in a death. Philips is in the process of obtaining add'l info regarding this incident and the complaint is still under investigation. A final report will be submitted once the investigation is completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610816-2010-00213 |
| MDR Report Key | 1736060 |
| Report Source | 05,06,07 |
| Date Received | 2010-06-22 |
| Date of Report | 2010-06-15 |
| Date of Event | 2010-05-25 |
| Date Mfgr Received | 2010-06-15 |
| Date Added to Maude | 2010-06-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NANCY SAYER |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS TC02 MODULE |
| Product Code | KLK |
| Date Received | 2010-06-22 |
| Model Number | M1018A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Death | 2010-06-22 |