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

Model Number	MODEL 100
Medical Device Problem Codes	Use of Device Problem (1670); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the preventive maintenance (pm) on (b)(6) 2022, the autopulse platform (sn (b)(4)failed initial functional testing due to fault 41 (patient temperature sensor failure) and failed brake gap inspection.No patient involvement.
Additional Manufacturer Narrative
During the preventive maintenance (pm) on (b)(6) 2022, the autopulse platform (sn (b)(4) failed initial functional testing due to fault 41 (patient temperature sensor failure) and failed brake gap inspection.The root cause for the observed fault 41 was a defective temperature sensor.The root cause for the autopulse platform failing the brake gap inspection was the brake gap was too wide, out of specification, and was not adjustable, likely due to a defective drivetrain motor.The root cause for the defective components is likely attributed to the aging of the device.The autopulse platform was manufactured in 2013 and is eight years old, well beyond the expected serviceable life of five years.Upon visual inspection, zoll service personnel noted a crack on the front enclosure, likely attributed to mishandling, such as a drop.The front enclosure needs to be replaced to address the observed physical damage.Upon further testing, zoll service personnel observed that the encoder drive shaft does not rotate smoothly and exhibits binding and resistance.The clutch plate was deburred to remedy the problem.The root cause was the sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate, or burrs on the clutch rotor's surface likely attributed to normal wear and tear.The sticky clutch's impact was not severe enough to make the platform non-functional.The temperature sensor and drivetrain motor need to be replaced to address the observed fault 41 and brake gap issue.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for 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: 14831206
• Report Number: 3010617000-2022-00720
• Device Sequence Number: 14660949
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/27/2022

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: 8700-0740-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2013
• 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