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

Model Number MODEL 100

Device Problem Device Operational Issue (2914)

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

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

It was reported that during patient use the autopulse platform (sn: (b)(4)) displayed user advisory (ua) 41 (patient temperature sensor failure ) error message.Multiple attempts were made to contact the reporter for additional information; however, were unsuccessful.No further information was provided.No known patient consequences reported.

Manufacturer Narrative

Functional evaluation of the returned autopulse platform was performed and ua41 (patient temperature sensor failure) error message was observed during testing, therefore confirming the reported complaint.The temperature sensor was replaced to remedy the issue.Once replaced , the autopulse passed the final functional testing with no issue observed.A review of the platform archive log showed there were numerous of faults ua41 appeared on (b)(6) 2016.A visual inspection of the returned autopulse platform was performed and found the top cover was cracked, encoder cover, motor cover was damaged and a missing battery partition cover.The autopulse platform is a reusable device and was manufactured on 12/19/2006, therefore this type of physical damages found during visual inspection are characteristics of normal wear and tear for the life of the device and is not related to the reported complaint.Additionally, unrelated to the reported complaint, the platform front enclosure, motor and encoder cover were replaced to fix the enclosure damage of the platform.The platform clutch plate and integrated gear box was also replaced to resolve the sticky clutch and ua27 (encoder fault (>3000 rpm) message observed during functional testing.Once completed, the autopulse passed the final functional test with no issue.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION 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: 6251739
• MDR Text Key: 64898548
• Report Number: 3010617000-2017-00036
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

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?: Yes
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2006
• 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