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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2014

Event Type  malfunction  

Event Description

Complainant alleged that during a shift check, the autopulse® platform stopped after performing a few compressions and then displayed a user advisory (ua) 17 (max motor on time exceeded during active operation) message, that was unable to be cleared.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

Product in complaint was returned to zoll on 12/12/2014 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 zoll (b)(4) for analysis.Visual inspection of the returned platform shows that the load plate cover was split/torn.The physical damage found during visual inspection is not related to the reported complaint that the platform displayed a ua17 (max motor on time exceeded during active operation) fault.The damage appears to have been caused by normal wear and tear (autopulse manufactured in 3/2008).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.Functional testing was performed and the reported complaint of ua17 fault was verified.It was observed that the motor drive train was defective.Based on the investigation, the parts identified for replacement were the motor drive train and the load plate cover.In summary, the reported complaint that the platform displayed a ua17 fault was confirmed during functional testing.The fault was found to be due to the motor drivetrain.The physical damage found during visual inspection is unrelated to the reported complaint.Upon replacement of all parts, the platform was re-evaluated through functional testing 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: 4362773
• MDR Text Key: 18266867
• Report Number: 3010617000-2014-00672
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/03/2014

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: 12/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2015
• Initial Date FDA Received: 12/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2008
• 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