MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-08-22 for NEO-THERM * STS-201 manufactured by Respiratory Support Products, Inc..
[183614]
Device broke and would not pick up baby's skin temp. No pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017034 |
| MDR Report Key | 237578 |
| Date Received | 1999-08-22 |
| Date of Report | 1999-08-22 |
| Date of Event | 1999-07-30 |
| Date Added to Maude | 1999-08-31 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEO-THERM |
| Generic Name | SKIN TEMPERATURE SENSOR |
| Product Code | HCS |
| Date Received | 1999-08-22 |
| Model Number | * |
| Catalog Number | STS-201 |
| Lot Number | 1576 |
| ID Number | HOSP # 7470 |
| Device Expiration Date | 2001-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 230229 |
| Manufacturer | RESPIRATORY SUPPORT PRODUCTS, INC. |
| Manufacturer Address | 2552 MCGAW AVE. IRVINE CA 92714 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-08-22 |