MAUDE Adverse Event Report: ZOLL CIRCULATION ELECTRIC CARDIAC RESUSCITATOR; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 100
Medical Device Problem Codes	Display Difficult to Read (1181); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During preventative maintenance (pm) of the autopulse platform (s/n (b)(4)), the zoll service personnel found that the lcd screen was dark/unreadable.The root cause of the observed issue was the defective processor board, likely due to the age of the device, wear and tear.The autopulse platform was manufactured in january 2011 and is over 10 years old, well beyond its expected service life of 5 years.During visual inspection, the front enclosure was observed cracked, unrelated to the noted lcd screen issue.The observed physical damage is likely attributed to user mishandling/neglect.There is no documented report showing that annual preventative maintenance (pm) was performed by zoll since the device was acquired by the customer in 2011.The front enclosure was replaced to address the issue.The autopulse platform was further examined, and it was noted that the power distribution board revision level was below 6, attributed to the age of the platform and unrelated to the noted lcd screen issue.The power distribution board was replaced to address the problem.The autopulse platform passed the initial functional test without any fault or error.A load cell characterization test was performed and verified that both load cells were functioning within the specification.During functional testing, the zoll service personnel noted that the backlight of the display flickered briefly when the platform was powered on, and it went dark afterward.Troubleshooting the problem determined that the processor board was defective, causing the lcd backlight issue.The defective processor board was replaced to remedy the fault.Following service, a brake gap inspection was performed and verified the brake gap was within the specification.The autopulse platform was subjected to a run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without any fault or error.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 preventative maintenance (pm) of the autopulse platform (s/n (b)(4)), the lcd screen was dark/unreadable.No patient involvement.

• Brand Name: ELECTRIC CARDIAC RESUSCITATOR
• 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: 13581999
• Report Number: 3010617000-2022-00183
• Device Sequence Number: 14634173
• Product Code: DRM
• UDI-Device Identifier: 00849111000574
• UDI-Public: 00849111000574
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: D163369
• 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): 02/22/2022

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: 8700-0730-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2011
• 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