MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-06 for MAX-N manufactured by Stryker Sustainability Solutions, Inc..
[99126994]
Patient Sequence No: 1, Text Type: N, H10
[99126995]
The nicu manager reported that lot# 7726303 of the stryker max-n pulse oximeter sensors were defective. When removing the pulse oximeter sensors from the paper that it adheres to, the metal wires on the sensor are exposed. All sensors from this lot were removed from the nicu and sequestered in central supply. None of these sensors had been used on any infant. The vendor was notified and will pick up the entire lot for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7243692 |
| MDR Report Key | 7243692 |
| Date Received | 2018-02-06 |
| Date of Report | 2018-01-26 |
| Date of Event | 2018-01-10 |
| Report Date | 2018-01-23 |
| Date Reported to FDA | 2018-01-23 |
| Date Reported to Mfgr | 2018-01-23 |
| Date Added to Maude | 2018-02-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 |
| Generic Name | OXIMETER, REPROCESSED |
| Product Code | NLF |
| Date Received | 2018-02-06 |
| Model Number | MAX-N |
| Lot Number | 7726303 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS, INC. |
| Manufacturer Address | 5300 REGION CT. LAKELAND FL 33815 US 33815 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-06 |