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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 Failure to Disconnect (2541); Connection Problem (2900); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 01/19/2018
Event Type  Malfunction  
Manufacturer Narrative

The customer report of the lifeband unable to remove out of the autopulse platform (sn (b)(4)) was confirmed during functional testing of the returned platform. The issue is due to the stiffness of the driveshaft. The autopulse platform is a reusable device and was manufactured on 13 mar 2008. It has exceeded its expected service life of 5 years and is about 10 years old. This observation is characteristic of normal wear and tear for the age of the device. The platform has not been sent for regular preventive maintenance. As part of routine service during testing, the platform was examined and found physical damages. This observation is also characteristic of normal wear and tear for the age of the device. A clutch plate deburring was performed to remedy the stiffness of the driveshaft. Following this, the damaged parts were replaced and the device was further functionally tested and passed all final specification. Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with serial (b)(4).

 
Event Description

The user reported that they were unable to remove the lifeband out of the autopulse platform (sn (b)(4)). It was stated that the rear pin does not rotate and would not release the lifeband, the lifeband was locked in place (stuck). The issue occurred after patient use and does not involve a patient.

 
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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 Key7263800
MDR Text Key100138016
Report Number3010617000-2018-00151
Device Sequence Number1
Product Code DRM
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK112998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/12/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 100
Device Catalogue Number8700-0700-01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/29/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/19/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/13/2008
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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