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

Model Number MODEL 100

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 05/20/2014

Event Type  malfunction  

Event Description

Complainant alleged that the autopulse® never worked as it should have.Complainant could not provide specific details, but indicated that there have been reports of the platform stopping compressions, turning off or displaying error messages.No adverse patient sequelae was reported.No further details were provided.

Manufacturer Narrative

Zoll has not yet received the product in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

Autopulse platform s/n (b)(4) was returned to zoll medical for evaluation.Visual inspection of the returned platform was performed and no damages were observed.Initial functional testing of the platform was performed and no faults or errors were exhibited.The platform ran for 7 minutes with a test mannequin and 3 minutes with the lrtf (large resuscitation test fixture) and no faults or errors were observed.A review of the archive was performed and no anomalies were noted on or around the reported event date of (b)(6) 2014, however multiple ua45 (not at "home" position"after power on/restart) and ua 18 (max take-up revolutions exceeded) errors were observed throughout the archive.A root cause for the ua45 errors was unable to be attributed to any specific component, therefore the root cause of the error is attributed to the lifeband not being properly pulled up prior to use (user error).A root cause of the ua 18 errors was also unable to be attributed to a specific component, however per the battery hangtag - advisory codes description and action (pn 12741-001), user advisory 18 is an indication that the autopulse has detected that either the patient's chest size is too small while sizing the patient (take-up) or that there is no patient on the platform.The customer's reported complaint that the platform was stopping compressions, turning off or showing unspecific error messages was confirmed through review of the platform archives.The customer experiencing multiple ua 45 and ua 18 errors were found throughout the autopulse archive.The root cause of these errors was determined to be user error as the platform functioned as intended during testing by zoll medical and all parts were determined to be within specification.

• 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: 3873112
• MDR Text Key: 4594454
• Report Number: 3003793491-2014-00283
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/20/2014

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 06/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2012
• 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