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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR
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ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; 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 07/07/2020
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 deployment for patient use, customer reported that the autopulse platform (serial #(b)(4)) displayed fault code 16 (timeout moving to take-up position) error message upon power up.User was unable to clear error message.Another autopulse platform was use to continue with compression.No consequences or impact to patient was reported.
 
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Brand Name
AUTOPULSE PLATFORM RESUSCITATION
Common Device Name
CARDIAC CHEST COMPRESSOR
Manufacturer (Section D)
ZOLL CIRCULATION
2000 ringwood ave.
san jose, ca
MDR Report Key10348330
Report Number3010617000-2020-00734
Device Sequence Number11628783
Product Code DRM
UDI-Device Identifier00849111001151
UDI-Public00849111001151
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/30/2020
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 Number8700-0740-24
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/08/2020
Initial Report FDA Received Date07/30/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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