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

Model Number MODEL 100

Device Problems No Display/Image (1183); Noise, Audible (3273)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During shift check, the autopulse platform (sn (b)(6)) made a clicking sound upon powering on.The lcd screen was consistently blank, and no messages were displayed.No patient involvement.

Manufacturer Narrative

The reported complaint that the autopulse platform (sn (b)(6)) made a clicking sound upon powering on, and the lcd screen was consistently blank was confirmed during a visual and functional inspection.The lcd screen was blank due to a malfunctioning processor board, preventing the platform from passing the initialization (power on self-test).This was likely due to failed component(s) on the processor board.Visual inspection of the returned autopulse platform revealed no physical damage.An archive review could not be performed because the platform failed the initialization (power on self-test), and the archive data could not be downloaded due to the failed processor board.The initial functional test couldn't be conducted due to the blank screen and continuous clicking noise, confirming the reported complaint.The malfunctioning processor board needs replacement to address this complaint.Unrelated to the reported complaint, further inspection found that the encoder driveshaft was getting stuck intermittently.This was attributed to a sticky driveshaft clutch area, usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the surface of the clutch rotor.The impact of the sticky clutch was not severe enough to make the platform non-functional.The clutch plate needs to be deburred to remedy the problem.Upon service completion, the platform will be subjected to final functional testing to ensure the device will pass all testing criteria.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for the autopulse platform with serial number (b)(6).

Manufacturer Narrative

Deburring and replacing the clutch plate did not resolve the stuck driveshaft issue.Therefore, the drivetrain motor assembly was replaced to remedy the problem.

• 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 nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17873785
• MDR Text Key: 324972000
• Report Number: 3010617000-2023-00865
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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