MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION SYSTEM; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	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	09/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported a complaint that the autopulse platform (sn (b)(6) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message was confirmed during the functional testing and archive data review.The root cause of the (ua) 07 error was due to the failed load cell module, likely attributed to a failed component or mishandling such as a drop.During visual inspection, there was no physical damage observed on the autopulse platform.The archive data indicated several (ua) 07 errors around the reported event date, thus, confirming the customer's reported complaint.The autopulse platform failed the initial functional testing due to the (ua) 07 error message displayed upon powering on, thus confirming the customer complaint.The load sensing system of the device has detected a weight/load imbalance between the two load cells.The load cell characterization test results confirmed that load cell module 1 was exceeding normal parameters.The load cell module needs to be replaced to address the reported complaint.During a further device inspection, unrelated to the reported complaint, the drivetrain motor brake assembly air gap was measured too wide, being out of specification.The probable root cause of this issue is attributed to wear and tear.The autopulse platform was manufactured in january 2011 and is over 12 years old, well beyond its expected service life of 5 years.The brake gap was adjusted within the specification to address the issue.Waiting on the customer's 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)(6).
Event or Problem Description
During the shift check, the autopulse platform (sn (b)(6) displayed a user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.No patient involvement.
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM
• Common Device Name: CARDIAC RESUSCITATOR, LINE-POWERED
• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18094535
• Report Number: 3010617000-2023-00944
• Device Sequence Number: 6753982
• Product Code: DRM
• UDI-Device Identifier: 00849111000079
• UDI-Public: 00849111000079
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: 100
• Device Catalogue Number: 8700-0700-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 07/26/2024
• 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