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

Model Number MODEL 100

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2019

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 worn out/chipped locking tabs on the bottom and front enclosure of the autopulse platform.The autopulse platform is a reusable device and was manufactured in march 2010.It has exceeded its expected service life of 5 years and is 9 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 top enclosure and encoder drive shaft does not rotate smoothly, exhibits binding and resistance, unrelated to the reported issue.All these observations are also characteristic of normal wear and tear attributed to the age of the device.The autopulse passed the initial functional test without any fault or error.A review of the archive was performed with no significant errors.After replacement of the defective and damaged components, the sticky clutch plate was deburred, the device was further functionally tested to full specification and passed all testing.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for autopulse with serial number (b)(4).

Event Description

As reported, during deployment, 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 pop out.The user attempted to troubleshoot by attaching multiple lifebands; however, the issue persisted.By holding the lifeband cover plate in the driveshaft slot the user was able to place the patient on the autopulse platform and start compressions.No manual cpr was performed.The platform performed continuous compressions during the entire call.No consequences or impact to patient was reported.

• 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: noemi schambach ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 8476418
• MDR Text Key: 140920007
• Report Number: 3010617000-2019-00247
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2019

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2010
• 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