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

Model Number MODEL 100

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

Complainant alleged that the autopulse® platform is displaying a fault code.The exact fault code is unknown.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

Product in complaint was returned to zoll on 12/19/2014 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 evaluation.Visual inspection was performed and no damages were observed.The reported complaint of the platform displaying a user advisory could not be duplicated during functional testing.The platform was run for 30 minutes with a test mannequin and no issues were encountered.The platform passed functional testing.The archive showed both user advisory 12 (lifeband® not present) and user advisory 18 (max take-up revolutions exceeded) codes occurring on the reported event date of (b)(6) 2014, thus confirming the reported complaint.Further inspection did not identify any issues with the platform that may have caused or contributed to the observed user advisories.As no issues were found with the platform, the probable cause of the ua 12 was the belt clip not being detected in the spool shaft due to improper connection of the lifeband onto the platform.The probable cause of the ua 18 was no load change detected at the load plate due to no object on the platform while it was in operation.Based on the investigation, there were no part(s) identified for replacement to address the reported complaint.In summary, the reported complaint of the platform displaying user advisories was confirmed during archive review.Both ua 12 and ua 18 codes were seen in the archive occurring on the reported event date.A cause for the ua codes could not be determined.However, probable causes include improper connection of the lifeband leading to the ua 12 and no object on the platform while it was in operation leading to the ua 18.Following service, the platform passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 4376142
• MDR Text Key: 21778825
• Report Number: 3010617000-2014-00684
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2014

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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2015
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2011
• 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