MAUDE Adverse Event Report: ZOLL CIRCULATION INC 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 Patient Involvement (2645)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform ((b)(4)) displaying a ua 45 (driveshaft not at "home" position after power-on/restart) error message was reproduced during functional testing and confirmed during archive data review.The autopulse platform is a reusable device and was manufactured on 13-mar-2008.It has exceeded its expected service life of 5 years, the device is over 10 years old.Evaluation of the platform during initial power up, revealed a ua 45 error message on the user control panel.The root cause is due to a defective driveshaft.The archive data was reviewed and confirmed the occurrence of the ua 45 error message on the reported event date of (b)(6) 2018.As part of routine service during testing, the device was examined and found physical damage.A load characterization check was performed and indicated a defective load cell.The defective driveshaft, observed physical damage, and defective load cell are all attributed to the wear and tear due to the age of the device.After replacement of the driveshaft, damaged parts and load cell, the platform was further tested and passed all final specification.Historical complaints were reviewed for service information related to the reported complaint and ccr (b)(4) was reported on (b)(6) 2014 for a ua 45 due to a driveshaft not being in home position.

Event Description

During routine inspection, the autopulse platform ((b)(4)) displayed an ua 45 (driveshaft not at "home" position after power-on/restart) error message.The user was unable to resolve the issue.Additionally, physical damage was also observed on the area near the driveshaft.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7526942
• MDR Text Key: 108689513
• Report Number: 3010617000-2018-00470
• 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: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• 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: 04/24/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• 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