MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-10-18 for ACUITY CENTRAL STATION ULTRA5-400 090-0022 manufactured by Welch Allyn Protocol, Inc..
[705806]
The user reported that the mouse froze up on the system. An attempt to power cycle using the power button did not work. The power cord plug was pulled to reboot the system. When the system came back up the system wouldn't boot. The user was walked through the reboot process and central monitoring was restored. Central monitoring was interrupted approximately one hour. Note 1: according to the device logs, the patient does not appear to have been identified during the time the system went down. There was a patient being monitored at the time of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
[8118456]
The device was rebooted and the issue was resolved. Root cause of the malfunction could not be identified through a review of the device log files.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3023750-2007-00277 |
| MDR Report Key | 930947 |
| Report Source | 05,06 |
| Date Received | 2007-10-18 |
| Date of Report | 2007-09-22 |
| Date of Event | 2007-09-22 |
| Date Mfgr Received | 2007-09-22 |
| Device Manufacturer Date | 2002-05-01 |
| Date Added to Maude | 2007-12-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROB 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 STATION |
| Product Code | MLD |
| Date Received | 2007-10-18 |
| Model Number | ULTRA5-400 |
| Catalog Number | 090-0022 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 929159 |
| Manufacturer | WELCH ALLYN PROTOCOL, INC. |
| Manufacturer Address | 8500 S.W. CREEKSIDE PLACE BEAVERTON OR 970087107 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-18 |