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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE® LI-ION BATTERY

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ZOLL CIRCULATION, INC AUTOPULSE® LI-ION BATTERY Back to Search Results
Model Number 8700-0752-01
Device Problem Charging Problem (2892)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/07/2014
Event Type  malfunction  
Event Description
It was reported that during biomed testing, the autopulse li-ion battery would not hold a charge.No patient involvement was reported.No further information was provided.Manufacturer has requested additional information; however, no additional information has been obtained.
 
Manufacturer Narrative
Zoll has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.
 
Event Description
Additional information provided by the customer: the reported event was found during a daily shift check.Customer indicated that when the battery came out of the autopulse multi-chemistry charger, one orange led was lit on the battery and the red led was lit on the charger (indicating that the battery is out of service).No further information was provided.
 
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Brand Name
AUTOPULSE® LI-ION BATTERY
Type of Device
LI-ION BATTERY
Manufacturer (Section D)
ZOLL CIRCULATION, INC
2000 ringwood ave.
san jose CA 95131
Manufacturer (Section G)
ZOLL CIRCULATION, INC
2000 ringwood ave.
san jose CA 95131
Manufacturer Contact
joy patel
2000 ringwood ave.
san jose, CA 95131
4084192957
MDR Report Key3724505
MDR Text Key4327539
Report Number3003793491-2014-00177
Device Sequence Number1
Product Code DRM
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K112998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 03/07/2014
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 Biomedical Engineer
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 04/04/2014
Initial Date FDA Received04/03/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/09/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2013
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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