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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 No Display/Image (1183); Noise, Audible (3273)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/15/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device associated with this complaint will not be returned for evaluation.Since the device was not returned, a physical investigation could not be performed, and a root cause could not be determined.In the case the device is returned, the complaint will be re-opened to perform an investigation.
 
Event or Problem Description
During the shift check, upon powering on of the autopulse platform (sn (b)(4)), the customer noticed that the lcd display was blank, and the platform made a loud clicking sound.Also, no response from any button was noted.No 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 Key10591149
Report Number3010617000-2020-00990
Device Sequence Number16791997
Product Code DRM
UDI-Device Identifier00849111002530
UDI-Public00849111002530
Combination Product (Y/N)N
Initial Reporter CountryKS
PMA/510(K) Number
K112998
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/26/2020
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 Number8700-0740-14
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/15/2020
Initial Report FDA Received Date09/26/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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