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	03/04/2020
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, customer reported that the autopulse platform (serial #(b)(4)) displayed a user advisory - "(ua) 41" (patient temperature sensor failure) error message and cracked black cover.No patient involvement.
Additional Manufacturer Narrative
The reported complaint of user advisory - ua41 (patient temperature sensor failure) error message on the autopulse platform (serial #(b)(6)) was not confirmed during functional test but confirmed during archive data review.Initial functional testing passed without any fault error.The returned autopulse platform performed as intended.Related to the reported complaint, a cracked front enclosure and unrelated to the reported complaint, damaged load plate cover were observed on the returned autopulse platform during visual inspection.These types of physical damages was likely attributed to wear and tear and/or mishandling.The front enclosure and load plate cover were replaced.Also, stiff manual rotation of drive shaft due to a sticky clutch was observed.The sticky clutch was likely attributed to wear and tear.Deburring was performed to remedy the sticky clutch.The autopulse platform was manufactured in september 2013 and it is nearly 7 years old, well past beyond its expected serviceable life of 5 years.During archive data review, no ua41 was recorded.Thus, not confirming the reported complaint.As a precaution, the temperature sensor was replaced.After parts replacements, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.Load cell characterization test passed.The autopulse platform passed all the functional tests.

• 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: 9914435
• Report Number: 3010617000-2020-00336
• Device Sequence Number: 16850979
• Product Code: DRM
• UDI-Device Identifier: 00849111000598
• UDI-Public: 00849111000598
• 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): 04/30/2020

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: 8700-0730-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1