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

Model Number MODEL 100

Device Problem Complete Loss of Power (4015)

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

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned, and investigation has been completed.

Event Description

During shift check, customer reported that the lifeband does not automatically adjust to the patient's chest and then the autopulse platform (sn (b)(6)) powers off by itself even though the battery and the lifeband were replaced.No patient involvement.

Manufacturer Narrative

The customer reported that the autopulse lifeband does not automatically adjust to the patient's chest and the autopulse platform (sn (b)(6)) kept shutting down.The reported complaint was confirmed in the archive data and during functional testing at zoll.A review of the archive data showed that on the reported event date, the autopulse platform failed to execute take-up multiple times while displaying fault code 16 (timeout moving to take-up position), and then the platform powered off.The root cause of fault code 16 was significant corrosion on the brake housing area of the drivetrain motor, most likely due to humidity and user handling practices.The storage condition of the platform is not known; however, the customer is in barbados, which is a high-humidity location.During visual inspection, no physical damage was noted.The archive data was reviewed and revealed multiple fault code 16 (timeout moving to take-up position) followed by multiple powers off around the event date, confirming the reported complaint.The autopulse platform failed the initial functional test due to fault code 16 displayed during take-up.While initiating take-up, the autopulse platform did not achieve the target depth within the specified time, and the platform shut down a few seconds later.Likely, the customer did not see the fault 16 displayed before the device powered off.The corrosion at the brake housing area was removed using ipa (isopropyl alcohol).A brake gap inspection was then performed and verified the brake gap was within the specification.Subsequently, the autopulse platform successfully passed a run-in test using the large resuscitation test fixture (lrtf) without any fault or error.Awaiting the customer's 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 serial number (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
• MDR Report Key: 17909485
• MDR Text Key: 325493688
• Report Number: 3010617000-2023-00861
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (y/n): N
• Reporter Country Code: BB
• 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: 01/10/2024

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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2021
• 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