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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/15/2015

Event Type  malfunction  

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.

Event Description

It was reported that the autopulse platform displayed a user advisory (ua) 16 (timeout moving to take-up position) message and was unable to initiate compressions.No adverse patient sequelae was reported.No additional details were provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll (b)(4) on 10/30/2015.Investigation results as follows: a visual inspection of the returned autopulse platform was performed and found that the short black cover was broken.This is not related to the reported complaint.Note this physical damage can occur due to normal wear and tear and/or physical abuse.A review of the platform was performed and user advisory (ua) 16 (timeout moving to take-up position).Ua16 was verified during functional testing.Further investigation found the drive train motor was defective causing the reported ua 16.Based on the investigation, drive train motor was replaced to remedy the reported complaint.In addition, the short black cover was also replaced.In summary, the customer's reported complaint of autopulse displaying ua 16 was confirmed during archive review and functional testing and was attributed to a defective drive train motor.After replacement of the parts identified during investigation, the platform passed all final functional 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: 5206826
• MDR Text Key: 30569677
• Report Number: 3010617000-2015-00622
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2015

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: 8700-0730-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 11/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2013
• 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