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 Inoperable (1663); 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

It was reported that the autopulse platform did not work as it should have due to non-specific reports of stopping compressions, turning off or displaying error messages.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 06/26/2014 for investigation.Investigation results as follows: visual inspection of the returned platform was performed and no damages to the platform were observed.Initial functional testing of the platform was performed and no faults or errors were exhibited.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 user advisory (ua) 45 (not at "home" position after power-on/restart) and ua 18 (max take-up revolutions exceeded) errors were noted throughout the archive.The root cause of 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).The root cause of the ua 18 errors was also unable to be attributed to a specific component.Therefore, per the battery hangtag - advisory codes description and action (pn 12741-001), the root cause is attributed to the autopulse detecting 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 platform underwent and met all final testing criteria.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's archives.The customer experiencing multiple ua 45 and ua 18 errors was 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 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: 3872330
• MDR Text Key: 4569767
• Report Number: 3003793491-2014-00281
• 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: 12/20/2011
• 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