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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
Device Problems Low Battery (2584); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 02/14/2018
Event Type  malfunction  
Manufacturer Narrative
The autopulse platform li-ion battery in complaint was returned to zoll on 03/08/2018 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
 
Event Description
During device check, the li-ion battery (sn: (b)(4)) was displaying as fully charged; however, only performed compression for a few moments when placed into the autopulse platform.No patient was involved.
 
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Brand Name
AUTOPULSE® LI-ION BATTERY
Type of Device
LI-ION BATTERY
Manufacturer (Section D)
ZOLL CIRCULATION
2000 ringwood ave.
san jose CA 95131
Manufacturer (Section G)
ZOLL CIRCULATION
2000 ringwood ave.
san jose CA 95131
Manufacturer Contact
kim thoa nguyen
2000 ringwood ave,
san jose, CA 95131
4084192922
MDR Report Key7342333
MDR Text Key102524942
Report Number3010617000-2018-00264
Device Sequence Number1
Product Code DRM
UDI-Device Identifier00849111001823
UDI-Public00849111001823
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial
Report Date 03/15/2018
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
Device Operator Health Professional
Device Model Number8700-0752
Device Catalogue Number8700-0752-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/14/2018
Initial Date FDA Received03/15/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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