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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 8700-0752-01
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that the latch of the autopulse li-ion battery broke off.No adverse patient sequelae was reported.No further information was provided.Please note that the customer did not provide the date of event.Manufacturer has requested additional information from the customer; however, no additional information has been obtained.
 
Manufacturer Narrative
The autopulse battery in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed if the product is returned and investigation has been completed.
 
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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
joy patel
2000 ringwood ave,
san jose, CA 95131
4084192957
MDR Report Key4728945
MDR Text Key5580651
Report Number3010617000-2015-00253
Device Sequence Number1
Product Code DRM
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 Health Professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 04/03/2015
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 Number8700-0752-01
Device Catalogue Number8700-0752-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/03/2015
Initial Date FDA Received04/24/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2014
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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