MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-11-28 for ACUITY CENTRAL MONITORING ULTRA 10 700-0348-00 manufactured by Welch Allyn Protocol, Inc..
[770557]
The keyboard became unplugged from the cpu. Unplugging the keyboard suspends the operating system on older type cpu's. The system required rebooting to restore device operation.
Patient Sequence No: 1, Text Type: D, B5
[8039845]
Method - tech support and engineering analyzed the log files to confirm system freeze. Results - the system freeze resulted from pulling the keyboard cable out. Even if it's reinserted, the system will freeze until rebooted. Mfr's evaluation summary: the device is an installed centralized pt monitoring system that utilizes a sun ultra 10 central processing unit (cpu). Oftentimes on the sun ultra systems, disconnecting the keyboard cable will cause the system to lock up. The customer called welch allyn tech support and identified that the keyboard had become detached and the operating system locked up. Tech support assisted the customer in rebooting the system and restoring normal operation 30 mins after the system originally became unresponsive. Even though centralized monitoring was lost during the time that the system was down, pt vital designs monitoring continued at bedside with the local beside pt monitor for any pts connected to the system. There were not pts harmed in any way by the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3023750-2007-00319 |
| MDR Report Key | 955624 |
| Report Source | 05,06 |
| Date Received | 2007-11-28 |
| Date of Report | 2007-10-29 |
| Date of Event | 2007-10-29 |
| Date Mfgr Received | 2000-10-29 |
| Device Manufacturer Date | 2001-08-01 |
| Date Added to Maude | 2008-03-11 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 MONITORING |
| Product Code | MLD |
| Date Received | 2007-11-28 |
| Model Number | ULTRA 10 |
| Catalog Number | 700-0348-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 960988 |
| Manufacturer | WELCH ALLYN PROTOCOL, INC. |
| Manufacturer Address | 8500 S.W. CREEKSIDE PLACE BEAVERTON OR 970087107 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-28 |