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 05/28/2018

Event Type  malfunction  

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; the root cause was due to the defective drive train motor brake assembly air gap being out of specification.The archive data was reviewed and contained a system error 139 (unable to hold compression position) error message on (b)(6) 2018.Evaluation of the platform during initial power up, revealed a system error, out of service, revert to manual cpr message.This was caused by the drive train motor brake assembly air gap being out of normal range.As part of routine service during testing, the platform was further examined and found user control panel backlight is flickering.This observation is not related to the reported event.Upon customer approval, the lcd and drive train motor will be replaced.The platform will be further tested to full specification.The autopulse platform is a reusable device and was manufactured on 08 jun 2009.It has exceeded its expected service life of 5 years, the device is over 9 years old.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse with serial number (b)(4).Ccr (b)(4), reported on (b)(6) 2013, replaced system processor board to remedy the issue.

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.

• 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: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7636489
• MDR Text Key: 112310656
• Report Number: 3010617000-2018-00663
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000116
• UDI-Public: 00849111000116
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• 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: 8700-0700-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2009
• 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