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 02/07/2024

Event Type  malfunction  

Event Description

During the shift check, the autopulse platform (sn (b)(6)) displayed a 'system error, out of service, revert to manual cpr' error message".No patient involvement.

Manufacturer Narrative

The customer reported a complaint that the autopulse platform (sn (b)(6)) displayed " system error, out of service, revert to manual cpr " error message was confirmed during the functional testing and based on the review of the archive data.The root cause of the system error is related to a communication error that caused a latch-up of the processor board.During visual inspection, the platform was examined and found a cracked front and bottom enclosures, and bent battery lock, unrelated to the reported complaint.This type of physical damage found during visual inspection is characteristic of the user mishandling, such as a drop.The front and bottom enclosures, and the battery lock were replaced to address the physical damage.Upon further testing, unrelated to the reported complaint, a sticky clutch plate was observed.This is usually caused by sharp edges from all 12-hex edges of the armature plate, or due to burrs on the clutch rotor's surface, likely attributed to normal wear and tear.The sticky clutch's impact was not severe enough to make the platform non-functional.The clutch plate was deburred to remedy the problem.During the archive data review, system error 132 (internal watchdog timeout) was observed, thus confirming the reported complaint.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering on, thus confirming the reported complaint.Ap vision software was used to reset the system error to remedy the issue.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.Waiting for customer approval for repair.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 sn (b)(6).

• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18813437
• MDR Text Key: 336866163
• Report Number: 3010617000-2024-00184
• Device Sequence Number: 1
• Product Code: DRM
• 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: 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
• 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: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2020
• 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