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	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn 31557) displaying user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) upon powering up was confirmed during archive data review and functional testing.The root cause of the ua07 was determined to be a loose cable connection between the load cell amplifier pca and the main platform pca processor.The noted electrical connection issue was possibly attributed to the device's age.The device's life expectancy is 5 years.The autopulse platform was manufactured in january 2011 and is over 13 years old.A review of the archive data showed multiple user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) on and around the customer's reported event date, confirming the reported complaint.Functional testing failed due to the ua07 advisory message displayed upon powering up the platform, confirming the reported complaint.The connection between the load cell amplifier pca and the main platform pca processor was loose, triggering the ua07 advisory messages.The load cell amplifier pca was securely re-connected to the main platform pca processor to address the problem.Subsequently, a load cell characterization test was performed and confirmed that both cell modules were functioning within the specification.Zoll is awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for the autopulse platform with serial number (b)(6).
Event or Problem Description
During shift check, the autopulse platform (sn (b)(6)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) upon powering up.No patient involvement.

• 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19668632
• Report Number: 3010617000-2024-00512
• Device Sequence Number: 17855414
• 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): 07/03/2024

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: 06/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/03/2024
• 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