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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELCH ALLYN INC. ACUITY CENTRAL MONITORING

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WELCH ALLYN INC. ACUITY CENTRAL MONITORING Back to Search Results
Model Number PRIMARY 22" FLAT PANEL
Device Problem Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/03/2017
Event Type  Malfunction  
Manufacturer Narrative

Troubleshooting performed by technical support confirmed that the display was powering off. Likely potential causes for no display are blown display fuse or blown capacitor, blown fuse to power supply, or power supply malfunction. Welch allyn replaced display to customer. No further investigation will be conducted.

 
Event Description

Welch allyn received a report from a welch allyn customer stating that their acuity display was powering down. A display that shuts off during use could result in a loss of centralized patient monitoring. There was no death or injury associated with this complaint. This report was filed in our complaint 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 INC.
4341 state street road
p.o. box 220
skaneateles falls 13166 0220
Manufacturer (Section G)
WELCH ALLYN
4341 state street road
p.o. box 220
skaneateles falls NY 13153 0220
Manufacturer Contact
edward o'neil
4341 state street road
p.o. box 220
skaneateles falls, NY 13153-0220
MDR Report Key6597522
MDR Text Key76154892
Report Number1316463-2017-00005
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
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 05/03/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/30/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator BIOMEDICAL ENGINEER
Device MODEL NumberPRIMARY 22" FLAT PANEL
Device Catalogue Number102756
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 Received05/30/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/30/2012
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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