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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During device evaluation on 8 feb 2023, the autopulse platform ((b)(4)) failed the load cell characterization test.No patient involvement.
Additional Manufacturer Narrative
During device evaluation on 8 feb 2023, the autopulse platform ((b)(4)) failed the load cell characterization test.The root cause of the observed failure was a failed load cell, likely attributed to failed component(s) or mishandling, such as a drop.Upon visual inspection, no physical damage was observed.During the initial functional testing, the autopulse platform display is missing pixel during power on, likely attributed to the age of the device.The autopulse platform was manufactured in 2008 and is 15 years old, past the expected serviceable life of 5 years.The lcd needs to be replaced to address this observed issue.The autopulse platform failed the load cell characterization test during the functional testing.The failed load cell module #2 needs to be replaced to address the observed failure.Further inspection, a component was found broken on the pca board, the pca must be replaced to address this observed issue.Zoll is waiting on customer's approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for the autopulse platform with (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: 16469513
• Report Number: 3010617000-2023-00217
• Device Sequence Number: 7671556
• 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): 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): 03/02/2023

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: 8700-0700-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2008
• 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