MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-01-29 for ACUITY CENTRAL MONITORING ACUITY SW 5.20.02 700-0363-00 manufactured by Welch Allyn Protocol, Inc..
[20925675]
The customer stated that the central monitoring sys had apparently rebooted, temporarily interrupting centralized pt monitoring. Pt vital signs monitoring continued uninterrupted at the bedside monitors. Centralized monitoring was restored within 60 minutes. Note: hosp staff reported that there were pts connected to the sys at the time, but did not report any pt id's.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3023750-2008-00033 |
| MDR Report Key | 991511 |
| Report Source | 05,06 |
| Date Received | 2008-01-29 |
| Date of Report | 2007-12-30 |
| Date of Event | 2007-12-30 |
| Date Mfgr Received | 2007-12-30 |
| Device Manufacturer Date | 2002-12-01 |
| Date Added to Maude | 2009-06-19 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BOB BERRY |
| Manufacturer Street | 8500 S.W. CREEKSIDE PLACE |
| Manufacturer City | BEAVERTON OR 970087107 |
| Manufacturer Country | US |
| Manufacturer Postal | 970087107 |
| Manufacturer Phone | 5035307500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUITY CENTRAL MONITORING |
| Product Code | MLD |
| Date Received | 2008-01-29 |
| Returned To Mfg | 2008-01-28 |
| Model Number | ACUITY SW 5.20.02 |
| Catalog Number | 700-0363-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN PROTOCOL, INC. |
| Manufacturer Address | 8500 S.W. CREEKSIDE PLACE BEAVERTON OR 97008710 US 97008 7107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-29 |