MAUDE Adverse Event Report: ZOLL CIRCULATION INC 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	01/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During preventive maintenance (pm) on 01/24/2022, the autopulse platform (b)(4) displayed a user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.The root cause for the observed failure was the defective load cells.The defective load cell modules are likely attributed to mishandling such as a drop or a defective component.Visual inspection of the returned platform was performed, and no physical damage was observed.The autopulse platform failed the initial functional testing due to the user advisory (ua) 07 error message displayed upon powering on.The load cell characterization test indicated that both load cells are defective.The defective load cells will be replaced to address the observed failure.Zoll is awaiting customer 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 autopulse platform with serial number (b)(4).
Event or Problem Description
During zoll's investigation on 01/24/22, the autopulse platform (b)(4) displayed user advisory - "(ua)07" (discrepancy between load 1 and load 2 too large) error message upon platform powering on.No patient involvement.
Additional Manufacturer Narrative
During preventive maintenance (pm) on (b)(6) 2022, the autopulse platform (b)(4) displayed a user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.The root cause for the observed failure was the defective load cells.The defective load cell modules are likely attributed to mishandling such as a drop or a defective component.Visual inspection of the returned platform was performed, and no physical damage was observed.The autopulse platform failed the initial functional testing due to the user advisory (ua) 07 error message displayed upon powering on.The load cell characterization test indicated that both load cells are defective.The defective load cells will be replaced to address the observed failure.Zoll is awaiting customer 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 autopulse platform with serial number (b)(4).
Event or Problem Description
During zoll's investigation on (b)(4) 2022, the autopulse platform (b)(4) displayed user advisory - "(ua)07" (discrepancy between load 1 and load 2 too large) error message upon platform powering on.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 13550272
• Report Number: 3010617000-2022-00141
• Device Sequence Number: 5060106
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/17/2022

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: Other
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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