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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); Device Operational Issue (2914)
Patient Problem No Patient Involvement (2645)
Event Date 08/10/2017
Event Type  Malfunction  
Manufacturer Narrative

The customer reported complaint for the platform having a concave power button was confirmed during visual inspection and initial functional testing. The power switch was replaced to remedy the fault. During visual inspection, loose battery clip, cracked screw support of top cover and concave power button were noted. Also, the brake gap was out of specification. The autopulse platform is a reusable device and was manufactured in 2010 therefore, this type of damage is characteristic of normal wear and tear for the life of the device. During initial functional testing, the platform did not power on due to the concave power button. Load characterization was performed and both cell modules are working within specification. An additional repair and update was completed (unrelated to the reported complaint) to ensure that the autopulse platform is functional without issue. The power distribution board (pdb) was not up to date; therefore was replaced. The brake gap and the battery clip were adjusted. The screw support of top cover was fixed, 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 related complaints for autopulse sn (b)(4).

 
Event Description

As reported during shift check, the autopulse platform (sn: (b)(4)) has a concave power button and was not working. No patient involvement was reported.

 
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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
noemi schambach
2000 ringwood ave,
san jose, CA 95131
4084192955
MDR Report Key6866942
MDR Text Key86439612
Report Number3010617000-2017-00718
Device Sequence Number1
Product Code DRM
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK112998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 09/14/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/14/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 100
Device Catalogue Number8700-0700-03
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/18/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/21/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/08/2010
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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