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

Model Number MODEL 100

Device Problems Crack (1135); Component Missing (2306); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 01/20/2015

Event Type  malfunction  

Event Description

Complainant alleged that the autopulse platform displayed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) message, that will not clear.It was also reported that the autopulse platform has a crack in the housing and the load plate screws are missing.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

Product in complaint was returned to zoll on 02/09/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for analysis.Visual inspection of the returned platform shows that one shoulder screw and the battery clip were missing, the top cover's wire strands were damaged and both top and front covers were cracked.The physical damages found during visual inspection confirmed the reported complaint.The damages appear to have been caused by normal wear and tear (autopulse manufactured in 7/2007).A review of the autopulse archive was performed and the archive data shows that no sessions occurred on the reported event date of (b)(6) 2015.However, the archive does show that a user advisory 7 (discrepancy between load 1 and load 2 too large) message occurred on (b)(6) 2015.Initial functional testing could not be performed due to the platform displaying a user advisory 45 (not at "home" position after power-on/restart) message upon power up.The ua45 fault was a result of the encoder shaft being one revolution off from its intended home position.The shaft was rotated back to the home position to remedy the ua45 fault.After power cycling the platform again, a user advisory 7 (discrepancy between load 1 and load 2 too large) message was displayed.Load cell characterization was performed and the data and graph showed that load cell module 1 was over reporting and causing a ua 7 to be displayed.Following replacement of the load cell, the platform was power cycled again and functionally tested, with no further ua codes or warnings being displayed.Based on the investigation, the parts identified for replacement were the top, front and bottom covers, battery clip and load cell module 1.In summary, the reported complaint of the platform missing the load plate screws and the platform having a crack in the housing was confirmed during visual inspection.The fault was found to be due to normal wear and tear.The reported complaint that the platform displayed a user advisory 7 fault was confirmed through review of the archive and during functional testing.The fault was found to be due to a defective load cell.Load cell module 1 was replaced to remedy the reported ua7 fault.Unrelated to the reported complaint, a ua45 fault was initially displayed during powering on the platform, prior to performing functional testing.The ua45 was attributed to the encoder shaft being out of its home position.The shaft was rotated back to the home position to remedy the ua45 fault.Upon replacement of all parts, the platform was re-evaluated through functional testing and the platform passed all testing criteria.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4518250
• MDR Text Key: 5445496
• Report Number: 3010617000-2015-00090
• Device Sequence Number: 1
• Product Code: DRM
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 02/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2007
• 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