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

Model Number MODEL 100

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (b)(4) was returned to zoll for evaluation.The customer complaint was confirmed during visual inspection.It was also found (unrelated to the reported complaint) that the battery lock was bent.To resolve the issue, the top cover was replaced.The autopulse platform is a reusable device and was manufactured on (b)(6) 2013.Therefore, this type of issue is characteristic of normal wear and tear for the life of the device.Review of the archive data found multiple user advisory (ua) 12 (lifeband not present) error messages had occurred on (b)(6) 2016 and ua 41 (patient temperature sensor failure) on (b)(6) 2016.During further investigation, the user advisory 12 (lifeband not present) error message appeared upon powering on the device.As a result, functional testing could not be performed.To resolve the ua 12, the switch arm assembly was adjusted so to be parallel to the case.The platform was tested and ran for approximately 30 minutes with no faults found.Although the ua 41 could not be duplicated during investigation, the power distribution board and temperature sensor cabling were replaced to avoid the reoccurrence of ua41.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).The platform passed all critical testing.

Event Description

It was reported that one of the shoulder restraint cable on the autopulse platform (b)(4) broke.The platform was returned to zoll for evaluation.During functional testing, a user advisory 12 (lifeband not present) error message appeared upon powering on the device and could not be cleared.There was 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 6216610
• MDR Text Key: 63690663
• Report Number: 3010617000-2016-00782
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/30/2016

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: 10/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2016
• Initial Date FDA Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2013
• 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