MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for PULSE OX 2021-06-14 manufactured by .
[128263150]
Pulse ox probe faulty, and wire exposed. This is a recycled pulse ox.. Mfr address: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081501 |
| MDR Report Key | 8090581 |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-11-05 |
| Date Added to Maude | 2018-11-20 |
| 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 | RISK MANAGER |
| 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 | PULSE OX |
| Generic Name | OXIMETER, REPROCESSED |
| Product Code | NLF |
| Date Received | 2018-11-19 |
| Model Number | 2021-06-14 |
| Lot Number | 8690504/8905749 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-19 |