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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR
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ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR Back to Search Results
Model Number MODEL 100
Medical Device Problem Codes Device Displays Incorrect Message (2591); Device Operational Issue (2914)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/12/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
 
Event or Problem Description
As reported during patient use, the autopulse platform (sn: (b)(4)) performed compression for approximately 3-4 minutes and then displayed error message user advisory (ua) 08 (motor controller fault detected) and 45 (not at "home" position after power-on/restart).Multiple attempts were made to contact the reporter for additional information; however, were unsuccessful.No further information was provided.No known patient consequences reported.
 
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Brand Name
AUTOPULSE® RESUSCITATION MODEL 100
Common Device Name
CARDIAC CHEST COMPRESSOR
Manufacturer (Section D)
ZOLL CIRCULATION
2000 ringwood ave.
san jose CA 95131
MDR Report Key6726011
Report Number3010617000-2017-00500
Device Sequence Number1003074
Product Code DRM
UDI-Device Identifier00849111000178
UDI-Public00849111000178
Combination Product (Y/N)N
Initial Reporter CountryNO
PMA/510(K) Number
K112998
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 07/19/2017
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
Operator of Device Health Professional
Device Model NumberMODEL 100
Device Catalogue Number8700-0700-20
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/21/2017
Initial Report FDA Received Date07/19/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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