MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-11-04 for HILL-ROM NI manufactured by Hill-rom, Inc..
[154426]
Additional info received from mfr on 12/17/98:no specified device listed in the report except as birthing bed. The info provided in the report does not contain: model, serial number, date of mfr. No source from which hill-rom can obtain info to address proposed questions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014884 |
| MDR Report Key | 195116 |
| Date Received | 1998-11-04 |
| Date of Report | 1998-11-04 |
| Date of Event | 1998-10-05 |
| Date Added to Maude | 1998-11-05 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | HILL-ROM |
| Generic Name | BIRTHING BED |
| Product Code | HHP |
| Date Received | 1998-11-04 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 189566 |
| Manufacturer | HILL-ROM, INC. |
| Manufacturer Address | 1069 STATE RT. 46 EAST BATESVILLE IN 470069167 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-11-04 |