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	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During preventative maintenance (pm), the autopulse platform (b)(6) passed the initial functional testing but later stopped in the middle of compressions due to user advisory (ua) 19 (max applied load exceeded).The root cause of the ua19 was the failed load cell #1, likely attributed to the age of the platform, failed component(s), or mishandling such as a drop.The autopulse platform was manufactured in december 2014 and is almost 9 years old, well beyond its expected service life of 5 years.The malfunctioning load cell will be replaced to remedy the fault.Visual inspection of the returned autopulse platform showed no apparent physical damage.Further inspection revealed that the encoder driveshaft could not rotate smoothly, exhibiting binding and resistance, unrelated to the noted ua19.The root cause of the observed issue was the sticky driveshaft clutch area.This is usually caused by sharp edges of the armature plate or burrs on the surface of the clutch rotor, likely due to wear and tear.The impact of the sticky clutch was not severe enough to make the platform non-functional.The clutch plate must be deburred to address the issue.A review of the archive data showed multiple user advisory (ua) 45 (not at "home" position after power-on/restart) and ua20 (position out of range).The root cause of the ua45 and ua20 was the malfunctioning integrated encoder gearbox, likely attributed to the age of the device.The integrated encoder gearbox should be replaced to address the ua45 and ua20 advisory messages.Further review of the archive data revealed ua02 (compression tracking error), which was determined to be related to the malfunctioning load cell #1.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 preventative maintenance (pm), the autopulse platform (b)(6) failed functional testing and displayed user advisory (ua) 19 (max applied load exceeded).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 thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18177426
• Report Number: 3010617000-2023-00985
• Device Sequence Number: 18055548
• Product Code: DRM
• UDI-Device Identifier: 00849111065108
• UDI-Public: 00849111065108
• 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): 07/24/2024

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: 8700-0700-03-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2014
• 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