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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELCH ALLYN PROTOCOL, INC. ACUITY CENTRAL MONITORING
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WELCH ALLYN PROTOCOL, INC. ACUITY CENTRAL MONITORING Back to Search Results
Model Number ACUITY 8.20.01
Device Problems Device Operates Differently Than Expected (2913); Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/28/2014
Event Type  malfunction  
Event Description
The customer reported that their acuity central station unexpectedly powered off during use.Engineering evaluation of acuity log files point to system panic likely due to a failing disk or memory.The cpu was exchanged and it is currently in the process of being returned to welch allyn for evaluation.There was no report of any patient harm as a result of the reported event.Note 1: the customer did not provide any patient information.
 
Manufacturer Narrative
The device evaluation is not yet complete.A follow-up report will be submitted when the evaluation is complete.
 
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Brand Name
ACUITY CENTRAL MONITORING
Manufacturer (Section D)
WELCH ALLYN PROTOCOL, INC.
8500 s.w. creekside place
beaverton OR 97008 710
Manufacturer Contact
robert berry
8500 s.w. creekside place
beaverton, OR 97008-7107
5035307500
MDR Report Key4270408
MDR Text Key5028266
Report Number3023750-2014-00032
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 10/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberACUITY 8.20.01
Device Catalogue Number713550
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/28/2014
Initial Date FDA Received11/12/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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