MAUDE Adverse Event Report: ZOLL CIRCULATION 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)
Type of Reportable Event	Malfunction
Event or Problem Description
During shift check, the autopulse platform (sn (b)(4) displayed "system error, out of service, revert to manual cpr" upon powering up.No patient involvement.
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(4) displayed "system error, out of service, revert to manual cpr" was confirmed during both archive data review and functional testing.The root cause of the system error was the processor board (pca) failure, likely due to the aging of the device.The autopulse platform was manufactured in june 2017 and is over 5 years old, passed its service life of 5 years.The contribution of user mishandling cannot be ruled out since the platform was returned damaged.During visual inspection, the bottom enclosure was cracked, unrelated to the reported complaint.This observed physical damage could be the characteristic of harsh impacts, attributed to user mishandling and neglect.No documented report was found showing that preventative maintenance (pm) was performed since the customer acquired the device in 2017.Archive data review showed the occurrence of system error - 132 (internal watchdog timeout), confirming the reported complaint.The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr" displayed upon powering up, confirming the customer's reported complaint.Technical investigation revealed that the root cause of the system error was the processor board failure, which was replaced to remedy the fault.Following service, a brake gap inspection was performed and verified the brake gap was within the specification.A load cell characterization test was performed and confirmed that both cell modules were functioning within the specification.The autopulse platform was subjected to a final 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 the autopulse platform with serial number (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: 15794850
• Report Number: 3010617000-2022-01950
• Device Sequence Number: 17341096
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2022

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: 8700-0740-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2017
• 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