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

Patient Problem No Patient Involvement (2645)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the zoll platform in complaint for investigation.A supplemental report will be filed when the investigation has been completed.

Event Description

The autopulse platform (sn (b)(4)) reportedly displayed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) and user advisory (ua) 41 (patient temperature sensor failure) error messages.The issue was observed during shift check, no patient was involved.

Manufacturer Narrative

The customer reported complaint for the platform displayed an error message user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) was confirmed during archive data review and functional testing.Load cell was found defective and a replacement was required.However, user advisory (ua) 41 (patient temperature sensor failure) error message was not confirmed in the archive review and the initial functional testing.There were no device deficiencies found during the evaluation of the platform, which could have caused or contributed to the reported (ua) 41 error message.As a precautionary measure, the temperature sensor cabling was replaced.Visual inspection was performed and found no physical damage to the autopulse platform.The platform failed the initial functional testing due to user advisory (ua) 07 error message, confirming customer complaint.Following the repair, the platform was further tested and passed all functional testing criteria and met all required specifications.Review of the archive data indicated multiple error messages (ua) 07 on the customer reported event date.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).

• 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: 7607105
• MDR Text Key: 111264699
• Report Number: 3010617000-2018-00637
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001076
• UDI-Public: 00849111001076
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• 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: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1