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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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.
 
Event or Problem Description
During the patient call, the customer reporting the contamination of the bodily fluids inside of the autopulse platform.In addition, the autopulse platform (sn (b)(4)) displayed a fault code 08 (motor controller fault detected).No further information was provided.No consequences or impact to patient.
 
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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 Key12257233
Report Number3010617000-2021-00689
Device Sequence Number14638342
Product Code DRM
UDI-Device Identifier00849111001151
UDI-Public00849111001151
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K112998
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/31/2021
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 Number8700-0740-24
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/02/2021
Initial Report FDA Received Date07/31/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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