MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-05 for STETHOSCOPE (NURSES) 30775-345 manufactured by Baxter Healthcare Corporation.
[1210]
Stethoscope was placed on top of radiant warmer. After the delivery of the baby, it was handed to the neonatalogist who examined the baby's chest with it. It was hot and burned the baby's skin. Left blister on left side of chestinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031 |
| MDR Report Key | 2031 |
| Date Received | 1993-01-05 |
| Date of Report | 1992-12-02 |
| Report Date | 1992-12-02 |
| Date Reported to FDA | 1992-12-02 |
| Date Added to Maude | 1993-01-07 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STETHOSCOPE (NURSES) |
| Product Code | LDE |
| Date Received | 1993-01-05 |
| Model Number | 30775-345 |
| Catalog Number | 30775-345 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 1887 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-01-05 |