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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 Visual Prompts will not Clear (2281)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/19/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll has not received the zoll 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, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 17 (max motor on time exceeded during active operation) error message.Unknown if the device issue was observed during the patient use or device check.No known impact or patient consequence was reported.No further information was provided.
 
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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 Key8507267
Report Number3010617000-2019-00286
Device Sequence Number1501344
Product Code DRM
UDI-Device Identifier00849111000659
UDI-Public00849111000659
Combination Product (Y/N)N
Initial Reporter CountryPO
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 Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/11/2019
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 Number8700-0730-24
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/20/2019
Initial Report FDA Received Date04/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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