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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 8.20.00
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/28/2013
Event Type  malfunction  
Event Description
Customer reported that their cpu had frozen, the system was rebooted but it froze again after 15 minutes.This resulted in a temporary inability to centrally monitor patients, however, bedside monitoring was not affected.There was no report of any patient harm as a result of the reported events.The customer did not provided 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 Key3845457
MDR Text Key4407047
Report Number3023750-2014-00007
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K120774
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 03/05/2014
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? Yes
Device Operator Health Professional
Device Model NumberACUITY 8.20.00
Device Catalogue Number713550
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/28/2013
Initial Date FDA Received03/11/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/01/2004
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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