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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

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

Event Date 02/10/2014

Event Type  malfunction  

Event Description

It was reported that during patient use, the autopulse platform performed compressions for one minute and then locked up.The display appeared to go into the administrative menu.No buttons would activate when pressed.Customer reverted to manual cpr.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

Zoll 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 on 03/04/2014 for investigation.Investigation results as follows: visual inspection was performed and the following was observed: the motor cover and front panel membrane were damaged.From the condition of the returned unit, the damages appeared to be due to normal wear and tear.During functional evaluation, the reported complaint was confirmed.Further inspection of the device determined that a defective processor board was causing the issue.Based on the condition of the returned unit, no further functional evaluation could be performed.The archive was corrupted and could not be retrieved for review.Based on the investigation, the part(s) identified for replacement in order to remedy the complaint was the system processor board.The ui membrane switch assembly and motor cover were also replaced.In summary, the reported complaint was confirmed during initial functional evaluation and found to be due to a defective system processor board.Following service, including replacement of the system processor board, the device passed all 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: 3658417
• MDR Text Key: 4319000
• Report Number: 3003793491-2014-00125
• 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: Paramedic
• Type of Report: Initial,Followup
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• 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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: MANUAL CPR