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

Model Number MODEL 100

Device Problem Device Alarm System (1012)

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

Event Date 07/02/2014

Event Type  malfunction  

Event Description

It was reported that the autopulse platform displayed a user advisory 45 (not at "home" position after power-on/restart) message.Customer attempted to clear the message by using the administrative menu to adjust the encoder counter to zero; however, the message did not clear.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(4) 2014 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection of the returned platform shows no physical damage to the platform.However, it was observed that the pem nut screws were missing.The missing screws found during visual inspection are not related to the reported event of a user advisory (ua) 45 (not at "home" position after power-on/restart) fault.The missing screws appear to have been caused by normal wear and tear (autopulse manufactured in june of 2005).A review of the autopulse archive was performed and the reported complaint of a ua 45 fault was confirmed.The archive data shows that multiple ua 45 faults occurred on the reported event date of (b)(6) 2014.Functional testing was performed and the reported issue of a ua 45 fault was not confirmed.The autopulse platform passed testing.Based on the investigation, the parts identified for replacement were the pem nut screws.In summary, the reported complaint of a ua 45 fault was confirmed based on the archive review but could not be reproduced during functional testing.The root cause for the ua 45 fault could not be determined.Per the autopulse® resuscitation system model 100 user guide (pn: 12555-001), if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.Upon replacement of the screws, the platform was re-evaluated through functional testing and passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 3954075
• MDR Text Key: 4605734
• Report Number: 3003793491-2014-00376
• 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: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• 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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2005
• 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