MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. AUTOPULSE®RESUSCITATION SYSTEM; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 03/24/2024

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform in complaint for investigation.A follow-up report will be filed if and when the product is returned and investigation has been completed.

Event Description

During device check before being used on the patient, the autopulse platform sn (b)(6)displayed "system error, out of service, revert to manual cpr".No patient involvement.

Manufacturer Narrative

The reported complaint that the autopulse platform (sn (b)(6) displayed "system error, out of service, revert to manual cpr" was confirmed in the archive data and during functional testing.The root cause of the system error was the drivetrain motor brake gap being too wide, out of specification.As a result, the autopulse stopped functioning with a system error, as designed.The brake gap issue is most likely attributed to the device's aging; the device's life expectancy is 5 years.The autopulse platform was manufactured in april 2017 and is over 7 years old.Reviewing the archive data showed a system error, 139 (unable to hold compression position), confirming the customer's reported complaint.The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr" upon powering up, confirming the reported complaint.Investigation revealed that the drivetrain motor brake gap was too wide, out of specification, which triggered the system error.The brake gap could not be adjusted within the specification; therefore, the drivetrain motor assembly needed to be replaced to remedy the problem.Upon replacement of the drivetrain motor, the platform was re-evaluated through the run_in test using a 95% large resuscitation test fixture (lrtf) with well-known 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)(6).

• Brand Name: AUTOPULSE®RESUSCITATION SYSTEM
• Type of Device: CARDIAC RESUSCITATOR, LINE-POWERED
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 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 ; 4084192347
• MDR Report Key: 19169547
• MDR Text Key: 340931429
• Report Number: 3010617000-2024-00339
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2024

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: 100
• Device Catalogue Number: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 08/08/2024
• Supplement Dates FDA Received: 08/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2017
• 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