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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2018

Event Type  malfunction  

Manufacturer Narrative

The product was returned to zoll on 06/14/2018 for investigation; however, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

As reported, the autopulse platform (sn (b)(4)) stopped working while being used on a female patient and then displayed a "system error, out of service, revert to manual cpr" error message.Hence, no known impact or consequence to the patient involved.

Manufacturer Narrative

The reported complaint of "system error, out of service, revert to manual cpr" on the autopulse platform (sn (b)(4) was confirmed during functional test and archive data review.It was determined that the root cause was due to air gap being out of specification on the drive train motor brake assembly.The air gap was observed too wide and could not be readjusted and continues to open out of specification.The setscrews would not lock into the encoder shaft dimple locking wells and caused the brake to disengage.The drive train motor needs to be replaced to remedy the reported issue.Initial functional testing could not be performed due to system error (latch 139) displayed upon platform power on and also, during archive data review, system error 139 (unable to hold compression position) was identified on (b)(6) 2018 (day of the event occurred), thus confirming the reported complaint.Unrelated to the reported issue, during the run_in test, the autopulse failed repeatedly due to user advisory 2 - compression tracking error occurred on the first compression.The load cell characterization confirming load cell module 1 was defective (underreport).During visual inspection, cracked front cover was observed (unrelated to the reported complaint).This type of physical damage on the device can occur due to normal wear and tear.As part of routine service, the damaged part was replaced.The autopulse platform is a reusable device and was manufactured in february 2008.The device has been operating over 10 years and has exceeded its expected serviceable life of 5 years.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint for autopulse serial number (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7644294
• MDR Text Key: 112566111
• Report Number: 3010617000-2018-00676
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• 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: 06/14/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1