MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-03-10 for ACUITY CENTAL MONITORING ACUITY 4.03.06 003-0139-00 manufactured by Welch Allyn Protocol, Inc..
[828888]
The customer reported that a terminal server used with their acuity centralized pt monitoring system had failed. The effect of this is to potentially inhibit centralized pt monitoring for one or more pts. There were no pts being monitored at the time of the reported event. There were no pts harmed in any way by the event.
Patient Sequence No: 1, Text Type: D, B5
[8048769]
The terminal server connects individual pt monitors to a computer cpu. The terminal server was not returned to welch allyn for eval and investigations of similar malfunctions have been conducted previously. The terminal server is a commercial off-the-shelf item that is not manufactured by welch allyn. The terminal server that is the subject of this report is obsolete and no longer supported by its mfr. Welch allyn responded to the customer's report by suggesting that they replace their obsolete equipment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3023750-2008-00077 |
| MDR Report Key | 1010112 |
| Report Source | 05,06 |
| Date Received | 2008-03-10 |
| Date of Report | 2008-02-11 |
| Date of Event | 2008-02-11 |
| Date Mfgr Received | 2008-02-11 |
| Device Manufacturer Date | 1996-12-01 |
| Date Added to Maude | 2008-06-11 |
| 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 | 0 |
| 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 CENTAL MONITORING |
| Product Code | MLD |
| Date Received | 2008-03-10 |
| Model Number | ACUITY 4.03.06 |
| Catalog Number | 003-0139-00 |
| 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 | 1006280 |
| Manufacturer | WELCH ALLYN PROTOCOL, INC. |
| Manufacturer Address | 8500 S.W. CREEKSIDE PLACE BEAVERTON OR 970087107 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-10 |