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 10-440 700-0274-02 manufactured by Welch Allyn Protocol, Inc..
[21346124]
The device (acuity) is an installed centralized patient monitoring system that utilizes a sun microsystems central processing unit (cpu). The device receives, analyzes and displays patient vital signs data from multiple bedside multifunctional patient monitoring devices through wired or wireless connections. The user returned the cpu to the factory for evaluation. Testing did not identify a problem. Factory service performed testing for 7 days in an attempt to duplicate the reported condition.
Patient Sequence No: 1, Text Type: N, H10
[21388641]
The customer reported that their system had been experiencing lockups, to the point where the system would not boot up. Note from a. 1. : the customer reported that there were five patients on the system when it failed. According to the customer, the staff does not id patients on the system, nor will they provide patient data.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3023750-2007-00317 |
| MDR Report Key | 955623 |
| Report Source | 05,06 |
| Date Received | 2007-11-28 |
| Date of Report | 2007-10-31 |
| Date of Event | 2007-10-31 |
| Date Mfgr Received | 2007-10-31 |
| Device Manufacturer Date | 2001-06-01 |
| 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 |
| Returned To Mfg | 2007-11-12 |
| Model Number | ULTRA 10-440 |
| Catalog Number | 700-0274-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 967452 |
| 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 |