MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-10-13 for NONE manufactured by .
[1699843]
.
Patient Sequence No: 1, Text Type: D, B5
[8748780]
Event resulted in an at-risk patient requiring hip surgery after a hospital fall. Per the uf report, the stryker medical bed "bed exit" alarm did not annunciate when the patient exited the bed. The bed alarm, integrated to the rauland responder 3 nurse call system, did not annunciate at the nurse's station as well. Multiple attempts to contact stryker medical were unsuccessful in order to secure the results of stryker's investigation. In the absence of stryker's investigation, rauland contacted the responsible biomedical engineer and reviewed the results of the hospital's investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000227151-2010-00001 |
| MDR Report Key | 1878170 |
| Report Source | 00 |
| Date Received | 2010-10-13 |
| Date Mfgr Received | 2010-08-06 |
| Device Manufacturer Date | 1984-01-01 |
| Date Added to Maude | 2010-10-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JONATHAN WACKS |
| Manufacturer Street | 1802 WEST CENTRAL ROAD |
| Manufacturer City | MOUNT PROSPECT IL 60056 |
| Manufacturer Country | US |
| Manufacturer Postal | 60056 |
| Manufacturer Phone | 8475907135 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | IQA |
| Date Received | 2010-10-13 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-13 |