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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Event or Problem Description
During shift check, the autopulse platform (sn: (b)(4)) displayed a user advisory (ua)41 (patient temperature sensor failure) error message.As reported, the platform was mistakenly stored in a laboratory for a few months prior to the reported issue.No patient involvement.
Additional Manufacturer Narrative
The reported complaint of "the autopulse platform (sn:(b)(6) displayed a user advisory (ua)41 (patient temperature sensor failure) error message" was confirmed based on the archive data review but not confirmed during the functional testing.Improper storage condition of the autopulse system most likely contributed to the occurrence of intermittent ua41.As per customer, the autopulse platform was mistakenly stored in a laboratory for a few months prior to the reported complaint.The ambient storage condition (e.G.Device sitting in a hot and humid environment and/or being exposed to direct sunlight for long hours) will increase the internal temperature of the autopulse platform and cause the occurrence of ua41 error message.Visual inspection of the returned platform was performed.Top cover was observed cracked in multiple places.Also, there was a small vertical crack running through the screw fitting of the front enclosure.The observed physical damages are unrelated to the reported complaint, and the root cause could be due to user mishandling.Top cover and front enclosure will be replaced to remedy the issue.A review of the autopulse platform archive was performed, and it showed multiple ua41 (patient temperature sensor failure) error messages; thus, confirming the reported complaint.In addition, review of the archive showed multiple user advisory (ua)11 (max patient temperature exceeded) error messages, unrelated to the reported complaint.The archive data showed high patient surface temperature due to intermittent functioning of the temperature sensor.During the initial functional testing of the returned autopulse platform, ua41 error could not be reproduced, and therefore, the reported complaint could not be confirmed.During the functional testing, the autopulse platform stopped after performing few compressions and displayed user advisory (ua)11 (max patient temperature exceeded) error message, unrelated to the reported complaint.The temperature sensor will be replaced as a preventive precautionary measure to address intermittent ua41 and ua11 error messages, as the sensor may have had some intermittent technical problems that could not be consistently identified during the functional testing.During further functional testing, it was noted that encoder driveshaft was stiff and could not rotate smoothly, unrelated to the reported complaint.The root cause was due to the sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the surface of the clutch rotor, likely attributed to normal wear and tear.Deburring and filing of the clutch plate will be performed to remedy the problem.Awaiting customer's approval for repair.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 9936644
• Report Number: 3010617000-2020-00357
• Device Sequence Number: 13641895
• Product Code: DRM
• UDI-Device Identifier: 00849111001090
• UDI-Public: 00849111001090
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1