MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-02-20 for ACUITY CENTRAL MONITORING ACUITY 5.20.04 700-0347-00 manufactured by Welch Allyn Protocol, Inc..
[801240]
The customer reported failure of the power supply that is located inside of the cpu (central processing unit) of a computer that is part of their acuity central station patient monitoring system. The customer further reported that they replaced the power supply and successfully restarted the monitoring system. Patient monitoring was interrupted for about two hours while they replaced the power supply. There was no patient harm associated with this report.
Patient Sequence No: 1, Text Type: D, B5
[8093535]
Method: the device was not returned to the manufacturer for evaluation. Evaluation of the device was performed by the customer. Conclusion: the customer reported that their replacement of the cpu's internal power supply unit corrected the malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3023750-2008-00056 |
| MDR Report Key | 1001362 |
| Report Source | 05,06 |
| Date Received | 2008-02-20 |
| Date of Report | 2008-01-21 |
| Date of Event | 2008-01-19 |
| Date Mfgr Received | 2008-01-21 |
| Device Manufacturer Date | 2002-09-01 |
| Date Added to Maude | 2008-05-06 |
| 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 SW 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 | 2008-02-20 |
| Model Number | ACUITY 5.20.04 |
| Catalog Number | 700-0347-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1000119 |
| Manufacturer | WELCH ALLYN PROTOCOL, INC. |
| Manufacturer Address | 8500 S.W. CREEKSIDE PLACE BEAVERTON OR 970087107 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-20 |