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 Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

Complainant alleged that the autopulse® platform is displaying a user advisory (ua) 12 (lifeband® not present) message, that is unable to be cleared.No adverse patient sequelae was reported.No further details were provided.

Manufacturer Narrative

Product in complaint was returned to zoll on 12/16/2014 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 analysis.Visual inspection of the returned platform shows that the bottom enclosure and the battery lock were damaged.The physical damages found during visual inspection are not related to the reported complaint that the platform displayed a user advisory 12 (lifeband® not present) fault.The damages appear to have been caused by normal wear and tear (autopulse manufactured in 1/2011).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) 2014.However, the archive data shows that multiple ua12 faults occurred on (b)(6) 2014.Functional testing was performed and the reported complaint was able to be reproduced.User advisory 12 was observed upon power up.It was noticed that the switch arm was out of adjustment.After the switch arm was readjusted, the platform was tested with a mannequin for approximately 14 minutes and no problems were found.Based on the investigation, the parts identified for replacement were the bottom enclosure, battery lock, and the battery cable.In summary, the reported complaint was confirmed based on review of the archive and during functional testing.The fault was found to be due to the switch arm needing to be readjusted.The physical damages found during visual inspection are unrelated to the reported complaint.Upon replacement of all parts, the platform was re-evaluated through functional testing with a large resuscitation test fixture equivalent to 250 pound patient, for approximately 20 minutes and 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: 4375961
• MDR Text Key: 5263816
• Report Number: 3010617000-2014-00683
• 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: 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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2011
• 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