MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-30 for PHILIPS 989803164281 manufactured by Philips Medical Systems.
[176979702]
Philips usb patient data cables arrived from the manufacturer and were defective. The end of the cable that interfaces with the device was too small so it would not stay safely in place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9647286 |
| MDR Report Key | 9647286 |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-15 |
| Report Date | 2020-01-23 |
| Date Reported to FDA | 2020-01-23 |
| Date Reported to Mfgr | 2020-01-30 |
| Date Added to Maude | 2020-01-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS |
| Generic Name | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) |
| Product Code | DSA |
| Date Received | 2020-01-30 |
| Model Number | 989803164281 |
| Catalog Number | 989803164281 |
| Lot Number | (10)201905030194 |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-01-30 |