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 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform was returned to zoll on 11 may 2018 for investigation; however, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

The autopulse platform (sn (b)(4)) displayed a "system error, out of service, revert to manual cpr" message upon power up.The reporter was unable to specify if the issue occurred during shift check or patient use.No known impact or patient consequence was reported.

Manufacturer Narrative

The report of the autopulse platform (sn (b)(4)) displaying a system error, out of service, revert to manual cpr message was confirmed during functional testing and archive data review.Upon visual inspection no physical damage was observed.Evaluation of the platform during initial power up, revealed a system error, out of service, revert to manual cpr message on the user control panel.The archive data was reviewed and contained a system error 132 (internal watchdog timeout) error message on the reported event date.The autopulse platform is a reusable device and was manufactured on 10 apr 2010.It has exceeded its expected service life of 5 years.Historical complaints were reviewed for service information related to the reported complaint and there was several similar complaints reported for autopulse with serial number (b)(4).Ccr 9639 reported on 22 may 2012, processor board replaced.Ccr 13852 reported on 24 sep 2013, ap vision3 software was used to clear the error.Ccr 23496 reported on 07 jul 2016, processor board replaced.Ccr 31894 reported on 14 jul 2017, processor board replaced.Ccr 37647 reported on 19 oct 2017, ap vision3 software was used to clear the error.Ccr 38304 reported on 11 dec 2017, apt vision3 software was used to clear the error.

• 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: 7571886
• MDR Text Key: 110175204
• Report Number: 3010617000-2018-00603
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/11/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1