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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During shift check, the autopulse platform sn (b)(4) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) upon powering on when there is no weight on the platform.No patient involvement.
Additional Manufacturer Narrative
The customer reported a complaint that "the autopulse platform sn (b)(4) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) upon powering on when there is no weight on the platform" was confirmed during the functional testing.The root cause of the ua07 was due to failed load cell(s), likely attributed to the age of the platform, failed component(s), or mishandling such as a drop.The autopulse platform was manufactured in 2011 and is 11 years old, well past the expected serviceable life of 5 years.Upon visual inspection, unrelated to the reported complaint, observed a hole on the load plate cover that affected the watertight seal, and one of the head restraints on the top cover was missing.The head restraint wire could have been cut to free the patient from the platform, or the user could have been lifting the platform by holding the head restraints.Missing head restraints do not render the autopulse platform non-functional.The root cause of the observed physical damages is likely attributed to user mishandling.The load plate cover and top cover need to be replaced to address the observed physical damages.The archive data indicated several ua07 on the reported event date, thus, confirming the customer's reported complaint.The autopulse platform failed functional testing due to ua07 displayed upon powering on and failed load cell characterization test due to failed load cell(s), thus, confirming the customer's reported complaint.The load cell(s) needs to be replaced to address the ua07.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse platform with sn (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15692627
• Report Number: 3010617000-2022-01901
• Device Sequence Number: 7385152
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2022

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: 10/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown