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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELCH ALLYN ACUITY CENTRAL MONITORING

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WELCH ALLYN ACUITY CENTRAL MONITORING Back to Search Results
Model Number ACUITY CPU
Device Problem Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2016
Event Type  Malfunction  
Manufacturer Narrative

Welch allyn field service engineer confirmed the customers allegation of the acuity having an on screen message of no video signal. Reboot of the system was unsuccessful. The cpu was replaced for the customer and the device is working without issue. The cpu is outside of the 3 year period after which the dfu defines the hardware components are to be replaced. Some potential root causes of the customers issue is a motherboard failure, processor failure. No further investigation will be conducted.

 
Event Description

Welch allyn received a report from a welch allyn customer stating that their acuity system was giving an error message of no video signal. When trying to restart the system, it would not reboot. A cpu failure could result in the loss of centralized monitoring. There was no patient/user injury reported. This report was filed in our complaint handling system as complaint (b)(4). The customer did not provide any patient information.

 
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Brand NameACUITY CENTRAL MONITORING
Type of DeviceACUITY
Manufacturer (Section D)
WELCH ALLYN
4341 state street road
p.o. box 220
skaneateles falls NY 13153 0220
Manufacturer (Section G)
WELCH ALLYN
4341 state street road
p.o. box 220
skaneateles falls NY 13153 0220
Manufacturer Contact
amy forbes
4341 state street road
p.o. box 220
skaneateles falls, NY 13153-0220
3156852597
MDR Report Key6300521
MDR Text Key66482319
Report Number1316463-2017-00002
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK052160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 07/25/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/03/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberACUITY CPU
Device Catalogue NumberACUITY CPU
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/23/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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