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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 Code Device Stops Intermittently (1599)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/02/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the autopulse platform for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
 
Event or Problem Description
The biomed reported that the autopulse platform (s/n: (b)(4)) stopped compression after 5 cycles.No error codes/messages were observed.No further information was provided and it is not known if there was patient involvement.
 
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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 Key5912741
Report Number3010617000-2016-00605
Device Sequence Number403810
Product Code DRM
UDI-Device Identifier00849111000550
UDI-Public00849111000550
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K112998
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer,foreign,user facilit
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 08/29/2016
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 Biomedical Engineer
Device Model NumberMODEL 100
Device Catalogue Number8700-0730-02
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/02/2016
Initial Report FDA Received Date08/29/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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