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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

The primary report of the autopulse platform (sn (b)(4)) rebooting upon button depression on the user control panel was not reproduced during functional testing.The secondary report of the platform displaying user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error messages was not reproduced during functional testing; however, was confirmed through archive data review.The archive data was reviewed and contained multiple ua 45 (driveshaft not at "home" position after power-on/restart) error message.As part of routine service during testing, the platform was examined and found physical damage on the top cover, motor cover, front enclosure, bent battery lock and corrosion on battery cabling.A load characterization check was performed and identified a defective load cell.These observation are not related to the reported event.Upon replacement of the damaged parts and load cell, the platform was further tested and passed all functional testing criteria and met all required specifications.The autopulse platform is a reusable device and was manufactured on 26 feb 2008.It has exceeded its expected service life of 5 years.The platform is 10 years old and has not seen regular preventive maintenance.Note that user advisory error messages are designed into the platform when one of several conditions is detected.Ua 45 alerts the operator that the autopulse driveshaft is not at its home position when the platform was powered on.This user advisory will persist until the driveshaft is returned to its home position.Per the autopulse user guide instruct, to clear ua 45, the operator needs to pull up the lifeband until the chest bands are full extended.This action will move the driveshaft to its home position.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaints reported for autopulse with serial number 21814.

Event Description

During shift check, the autopulse platform (sn (b)(4)) will reboot upon button depression on the user control panel.The user was unable to resolve the issue.Additionally, during compression testing the platform displayed user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message on the user control panel.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: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7644293
• MDR Text Key: 112566828
• Report Number: 3010617000-2018-00675
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2018

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: 06/11/2018
• 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: 02/26/2008
• 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