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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 Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2014
Event Type  malfunction  
Event Description
Complainant alleged that during a shift check, it was observed that the light emitting diodes (leds) on the autopulse li-ion battery would not function.There was no report of any patient involvement.No further details were provided.
 
Manufacturer Narrative
Zoll circulation 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.
 
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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 Key3658896
MDR Text Key4281323
Report Number3003793491-2014-00130
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 02/12/2014
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 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 02/12/2014
Initial Date FDA Received03/04/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2013
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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