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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 Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/25/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll has received the zoll platform in complaint for investigation.A supplemental report will be filed when the investigation has been completed.
 
Event or Problem Description
During patient use, customer reported that the autopulse stopped compressions after several minutes of operation.The crew immediately switched to lucas chest compression system.No patient harm or consequences were 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 Key7223504
Report Number3010617000-2018-00157
Device Sequence Number2248254
Product Code DRM
UDI-Device Identifier00849111065108
UDI-Public00849111065108
Combination Product (Y/N)N
Initial Reporter CountryJA
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) 01/26/2018
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 Number8700-0700-03
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 01/09/2018
Initial Report FDA Received Date01/26/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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