MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-24 for PHILIPS SURESIGNS VS3 manufactured by Philips Medical Systems.
[146475294]
Philips medical sent out two (2) recalls on the vs3 and vs4 monitors. The software was to patch a battery issue (fsn86000266a) and spo2 issue (z-1317-2019). The software update then locked all monitors that were using non-philips batteries. For our organization, it would make 1183 devices non-functional. This would create a serious safety issue for our healthcare facilities. Additionally, the details regrading this change were not fully disclose. We have stopped installing the upgrades believing that the risk of losing these monitor was greater than the safety improvement from the upgrade. This appears to be a restriction of trade rather than a true recall. Test date: (b)(6) 2019. Monitor non-functional after installation of software. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086924 |
| MDR Report Key | 8645997 |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-05-10 |
| Date Added to Maude | 2019-05-28 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | BIOMEDICAL ENGINEER |
| 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 | 0 |
| Brand Name | PHILIPS SURESIGNS VS3 |
| Generic Name | ALARM, BLOOD-PRESSURE |
| Product Code | DSJ |
| Date Received | 2019-05-24 |
| Model Number | VS3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Brand Name | PHILIPS SURESIGNS VS4 |
| Generic Name | ALARM, BLOOD-PRESSURE |
| Product Code | DSJ |
| Date Received | 2019-05-24 |
| Model Number | VS4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-24 |