MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

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.

• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7263800
• MDR Text Key: 100138016
• Report Number: 3010617000-2018-00151
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1