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	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During servicing at zoll, the autopulse platform (b)(6) failed initial functional testing due to fault 27 (encoder fault).The root cause for the observed fault was due to a failure of the integrated encoder gearbox, likely attributed to the age of the device.The autopulse platform was manufactured in 2008 and is 16 years old, past its expected service life of 5 years.Upon visual inspection, a cracked /damaged top cover and a hole that affects the watertight seal of the load plate cover were observed.The probable root cause for the observed physical damages was due to mishandling.Also, the brake gap was too wide (out of specification), likely attributed to wear and tear due to the age of the device.The initial functional testing of the ap platform could not be performed due to the displayed fault 27 (encoder fault).The encoder will need to be replaced to remedy the fault code.However, the repair was rejected by the customer and the device will be disposed of by zoll germany.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints for autopulse platform with (b)(6).
Event or Problem Description
During servicing at zoll, the autopulse platform (b)(6) failed initial functional testing due to fault 27 (encoder fault).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: 18813467
• Report Number: 3010617000-2024-00176
• Device Sequence Number: 8271606
• Product Code: DRM
• UDI-Device Identifier: 00849111001076
• UDI-Public: 00849111001076
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/29/2024

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: Other
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 02/29/2024
• 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