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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 Break (1069); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2013
Event Type  malfunction  
Event Description
It was reported that during a daily shift check, the autopulse platform displayed a system error message upon power up.Customer also reported that the blue case is broken.No patient involvement was reported.No further information was provided.
 
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.
 
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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 Key3548912
MDR Text Key15265504
Report Number3003793491-2014-00004
Device Sequence Number1
Product Code DRM
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 12/13/2013
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 NumberMODEL 100
Device Catalogue Number8700-0700
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/13/2013
Initial Date FDA Received01/02/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2008
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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