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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 Device Inoperable (1663); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 12/13/2017
Event Type  Malfunction  
Manufacturer Narrative

The reported complaint was confirmed during archive review but not during initial functional testing. The root cause for the platform stop compressing was caused by error message user advisory (ua) 17 (max motor on time exceeded) due to the drive shaft not reaching the target depth within specification due to the medium/large size stiff to compress patient. There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint. User advisory error messages are designed into the platform when one of several conditions is detected. Ua 17 alerts the user that the drive motor did not reach the target depth within specification when used on a medium/large size stiff patient and when the battery being used has a low voltage. No physical damage was noted during visual inspection. The encoder drive shaft does not rotate smoothly, exhibits binding and resistance. The archive data review indicated error message ua 17 on (b)(6) 2017 but not on (b)(6) 2017. Based on the archive, the li-ion battery with serial number (b)(4) was used and the platform performed 2046 compressions on a large stiff patient. The platform stopped performing compression due to error message ua 17. The user pressed restart to clear the fault and a different li-ion battery with serial number (b)(4) was used. The platform then performed 102 compression on the same large stiff patient before stopped compression with ua 17 and low battery warning error message. The platform passed the initial functional testing without any issues. No brake activation was noted when the unit was powered on due to the drive train motor brake gap being out of specification. Brake gap adjustment was performed and run-in test was performed using large resuscitation test fixture (lrtf) with known good batteries until discharged without any issues. An additional repair and update was completed (unrelated to the reported complaint) to ensure that the autopulse platform is functional without issue. The clutch plate deburring was performed; after which the platform passed all the final functional testing. Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints for autopulse sn (b)(4).

 
Event Description

During shift check, the autopulse platform (sn: (b)(4)) stopped working after performing compression for 30 minutes. No patient was involved.

 
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Brand NameAUTOPULSE® RESUSCITATION MODEL 100
Type of DeviceCARDIAC 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
kim thoa nguyen
2000 ringwood ave,
san jose, CA 95131
4084192922
MDR Report Key7179723
MDR Text Key96963229
Report Number3010617000-2018-00014
Device Sequence Number1
Product Code DRM
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK112998
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 01/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 100
Device Catalogue Number8700-0740-02
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/15/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/13/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/20/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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