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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse platform (b)(6) displayed "system error, out of service, revert to manual cpr" was confirmed during archive data review and functional testing.The root cause of the system error was the malfunctioning processor board due to failed component(s).The reported complaint that the lcd screen of the autopulse platform was pixilated upon being powered on was not confirmed during the visual and functional tests.The platform's lcd screen was functioning as expected.The reported complaint that there was a tear on the load plate cover of the platform was confirmed during the visual inspection.A noticeable cut (opening) was observed on the load plate cover, attributed to user mishandling.The load plate cover was replaced to address the issue.Archive data review showed the occurrence of system error 132 (internal watchdog timeout) around the customer's reported event date, 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 reported complaint.Technical investigation revealed that the cause of the system error was the processor board failure, which was replaced to remedy the fault.Following service, the autopulse platform was subjected to run-in tests using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without 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)(6).

Event Description

During morning shift checks, the customer noticed that the lcd screen of the autopulse platform (b)(6) was pixelated when powered on, and the platform displayed "system error, out of service, revert to manual cpr".Also, the customer observed a tear on the load plate cover of the platform.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18964407
• MDR Text Key: 338428949
• Report Number: 3010617000-2024-00241
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1