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

Model Number MODEL 100

Device Problems Connection Problem (2900); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

The customer report of the lifeband unable to be properly installed in the autopulse platform (sn (b)(4)) was confirmed during functional testing of the returned platform.The issue is attributed to a defective belt clip retainer and monolithic plunger.The autopulse platform is a reusable device and was manufactured on 29 dec 2007.It has exceeded its expected service life of 5 years and is over 10 years old.This observation is characteristic of normal wear and tear for the age of the device.As part of routine service during testing, the platform was examined and found physically damaged front enclosure and battery lock, and a defective user control panel lcd.A load characterization check was performed and found that the load cell needs replacement.All these observations are also characteristic of normal wear and tear attributed to the age of the device.Upon customer approval, the defective and damaged components will be replaced and the device will be further functionally tested to full 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

During routine check, the autopulse platform (sn (b)(4)) was tested and found that the lifeband was unable to be properly installed in the driveshaft slot - the lifeband pops out.The user tested the lifeband in another platform and was able to properly perform installation without any issue observed.No patient involvement.

• 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: 7291067
• MDR Text Key: 101015780
• Report Number: 3010617000-2018-00172
• 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: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/02/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2007
• 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