MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-05-23 for ACUITY CENTRAL STATION ACUITY SW 4.03.06 700-0274-02 manufactured by Welch Allyn Protocol, Inc..
[16719520]
The customer reported that the central station cpu (central processing unit) was intermittently rebooting and subsequently would not operate. Note 1 for block a1: the reporter was not able to indicate if any pts were connected to the system at the time of the product problem.
Patient Sequence No: 1, Text Type: D, B5
[16953161]
Method - analysis of system log files. Results - cpu module. Conclusions: device failure confirmed; device replaced. The device is an installed centralized pt monitoring system that utilizes a sun micro-systems model ultra 10 computer and related computer network peripherals. The device receives, analyzes and displays patient vital signs data from multiple bedside multi-functional patient monitoring devices through either wired or wireless connections. Eval of the device confirmed the reported problem and investigation isolated the problem to a failed cpu module within the sun microsystems computer. The evidence suggests that the problem likely happened as a result of shipping damage that occurred when the device was last returned to the customer. Analysis of our service data for the sun model ultra 10 (including a similar marketed device, the model ultra 5) shows no adverse trend over time for cpu module failure. The subject device (computer) was more than seven years old at the time of the reported malfunction. The customer was provided with a replacement product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3023750-2008-00133 |
| MDR Report Key | 1051214 |
| Report Source | 05,06 |
| Date Received | 2008-05-23 |
| Date of Report | 2008-04-25 |
| Date of Event | 2008-04-25 |
| Date Mfgr Received | 2008-04-25 |
| Device Manufacturer Date | 1994-10-01 |
| Date Added to Maude | 2009-07-27 |
| 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 | ROBERT 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 | 2008-05-23 |
| Returned To Mfg | 2008-05-05 |
| Model Number | ACUITY SW 4.03.06 |
| Catalog Number | 700-0274-02 |
| Lot Number | NONE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2008-05-23 |