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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE® RESUSCITATION SYSTEM MODEL 100; CARDIAC CHEST COMPRESSOR
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ZOLL CIRCULATION, INC AUTOPULSE® RESUSCITATION SYSTEM MODEL 100; CARDIAC CHEST COMPRESSOR Back to Search Results
Model Number MODEL 100
Device Problems Sticking (1597); Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 07/21/2014
Event Type  malfunction  
Event Description
It was reported that during a shift check, the autopulse platform displayed a user advisory (ua) 16 (timeout moving to take-up position) message upon power up.Customer also reported that the motor was stuck and would not move.No patient involvement was reported.No further information was provided.
 
Manufacturer Narrative
Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
 
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Brand Name
AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
Type of Device
CARDIAC CHEST COMPRESSOR
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 Key4003736
MDR Text Key4956567
Report Number3010617000-2014-00412
Device Sequence Number1
Product Code DRM
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K112998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 07/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMODEL 100
Device Catalogue Number8700-0700-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/22/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/12/2011
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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