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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR
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ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR Back to Search Results
Model Number MODEL 100
Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/11/2018
Event Type  malfunction  
Manufacturer Narrative
Zoll has not yet received the product for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
 
Event Description
During shift check, inspection the autopulse platform (sn (b)(4)) displayed user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) error message upon power up.User was unable to clear the ua 7 error message.No patient involvement.
 
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Brand Name
AUTOPULSE® RESUSCITATION MODEL 100
Type of Device
CARDIAC CHEST COMPRESSOR
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
kimthoa nguyen
2000 ringwood ave,
san jose, CA 95131
4084192922
MDR Report Key7579975
MDR Text Key110459460
Report Number3010617000-2018-00621
Device Sequence Number1
Product Code DRM
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K112998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial
Report Date 06/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
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-XX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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