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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 SUN PLATFORM CPU
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2014
Event Type  malfunction  
Event Description
The customer reported that their acuity central station display monitors frequently freeze for 10-15 seconds, requiring system reboot to resolve the issue.There was no report of any pt harm as a result of the reported event.The customer did not provide any pt info.
 
Manufacturer Narrative
Log files were obtained and are currently being investigated.A follow up report will be submitted following the investigation.
 
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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 Key4235013
MDR Text Key21931819
Report Number3023750-2014-00023
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 08/06/2014
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 NumberSUN PLATFORM CPU
Device Catalogue Number713550
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/06/2014
Initial Date FDA Received09/05/2014
Was Device Evaluated by Manufacturer? No
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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