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

Model Number MODEL 100

Device Problem Device Inoperable (1663)

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

Event Type  malfunction  

Event Description

Complainant alleged that during patient use, the autopulse resuscitation system would not work.According to the customer the issue was the lifeband.No adverse patient sequelae was reported.Manufacturer has made a couple of attempts to obtain additional information, however, no further details have been provided.;please note that date of event was not provided.

Manufacturer Narrative

Customer also reported that they tested the autopulse on the morning of (b)(6) 2014, and it would not turn on at first.Once the battery was removed from the autopulse and placed back in, the unit worked fine.The platform was used on a mannequin and it performed 6 rounds of compressions without any observed issues.Zoll circulation has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll (b)(4) on 06/24/2014 for investigation.Investigation results as follows: visual inspection of the returned platform was performed and found the head restraint to be cracked.Functional testing of the platform was performed using zoll test batteries and no faults or errors were exhibited.A review of the archive was performed and found multiple user advisory (ua) 12 (lifeband not present) messages to have occurred on (b)(6) 2014, which is consistent with the customer's reported complaint of having issues with the lifeband.The root cause of the ua 12 was determined to be that the lifeband was not properly installed in the autopulse platform.Parts replaced not related to the reported complaint to ensure that the autopulse platform is functioning without issue: the head restraint was replaced, as it was found to be cracked during visual inspection.The platform underwent and met all final 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: 3597872
• MDR Text Key: 4066066
• Report Number: 3003793491-2014-00047
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2004
• 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