MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-28 for MAX-N NEONATAL/ADULT O2 TRANSDUCER DWG5120-05 manufactured by Stryker.
[25007743]
Pulse oximeter cable on baby's foot had exposed intact wires near end that connects to baby's foot. Covering came off wires to expose the wires. Cable no marked or reddened areas noted on affected foot, skin intact. No harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055904 |
| MDR Report Key | 5053602 |
| Date Received | 2015-08-28 |
| Date of Report | 2015-08-28 |
| Date of Event | 2015-08-26 |
| Date Added to Maude | 2015-09-03 |
| 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 |
| 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 | MAX-N NEONATAL/ADULT O2 TRANSDUCER |
| Generic Name | MAX-N NEONATAL/ADULT O2 TRANSDUCER |
| Product Code | MMA |
| Date Received | 2015-08-28 |
| Model Number | DWG5120-05 |
| Lot Number | 3819748 |
| ID Number | 109283449 |
| Device Expiration Date | 2018-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Manufacturer Address | LAKELAND FL 33815 US 33815 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-28 |