MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. 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	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (b)(6) displayed user advisory (07) (discrepancy between load 1 and load 2 too large) was confirmed during both archive data review and functional testing.The root cause of the ua07 was the malfunctioning load cell #2, likely attributed to the device's aging, failed component(s), or mishandling such as a drop.The device's life expectancy is 5 years.The autopulse platform was manufactured in august 2017 and is over 7 years old.A review of the archive data showed multiple user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) 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.Load cell characterization test results revealed that load cell #2 was over-reporting, and it needs to be replaced to remedy the fault.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
The customer reported that during shift check, the autopulse platform (b)(6) displayed user advisory (07) (discrepancy between load 1 and load 2 too large).No patient involvement.
Additional Manufacturer Narrative
The root cause of the ua07 was that both the load cells were malfunctioning.To remedy the fault, both the defective load cells were replaced.Following service, the autopulse platform passed all testing criteria.

• Brand Name: AUTOPULSE®RESUSCITATION SYSTEM
• Common Device Name: CARDIAC RESUSCITATOR, LINE-POWERED
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 20185702
• Report Number: 3010617000-2024-00745
• Device Sequence Number: 18323609
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2017
• 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