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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LI-ION BATTERY
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ZOLL CIRCULATION AUTOPULSE® LI-ION BATTERY Back to Search Results
Model Number 8700-0752
Medical Device Problem Code Battery Problem (2885)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/12/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The autopulse li-ion battery in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed if and when the product is returned and investigation has been completed.
 
Event or Problem Description
It was reported that the autopulse battery (sn unk) was inserted in the autopulse platform (sn (b)(4)) and the user had to repeatedly press the power button before the platform was able to initialize.Following this, the platform performed continuous compression for an unspecified amount of time; however, eventually powered off.No known impact or patient consequence was reported.
 
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Brand Name
AUTOPULSE® LI-ION BATTERY
Common Device Name
LI-ION BATTERY
Manufacturer (Section D)
ZOLL CIRCULATION
2000 ringwood ave.
san jose CA 95131
MDR Report Key6836072
Report Number3010617000-2017-00689
Device Sequence Number11120406
Product Code DRM
UDI-Device Identifier00849111002042
UDI-Public00849111002042
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K112998
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 08/31/2017
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 Number8700-0752
Device Catalogue Number8700-0702-01
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/16/2017
Initial Report FDA Received Date08/31/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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