MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION; 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	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During preventative maintenance (pm) performed at zoll, the autopulse platform (sn (b)(4)) displayed a fault code 08 (motor controller fault detected) error message.The root cause for fault code 08 was due to a defective drive train motor due to wear and tear.The autopulse platform was manufactured in march 2012 and is almost 10 years old, well past its service life of 5 years.The drive train motor needs to be replaced to address the observed fault.Upon visual inspection, noticed a cracked top cover and a damaged battery bay.The probable root cause for the observed physical damage could be due to user mishandling such as a drop.The top cover and the battery bay need to be replaced to address the observed physical damage.The load cell characterization test was performed and confirmed both cell modules are functioning within the specification.Waiting for 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 autopulse platform with sn (b)(4).
Event or Problem Description
During preventive maintenance on (b)(6) 2021, the autopulse platform (sn (b)(4)) failed functional testing due to the fault code 8 (motor controller fault detected) error message.No patient involvement.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• 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: 12930117
• Report Number: 3010617000-2021-01116
• Device Sequence Number: 3948681
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2021

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: 10/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2012
• 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