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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

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

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the drive shaft of the autopulse platform (sn (b)(6)) could not be returned to the home position and the platform displays a persistent user advisory (ua) 45 (not at "home" position after power-on/restart) error message was confirmed during archive data review and functional testing.The root cause for the reported complaint was a failure of the integrated encoder gearbox, likely attributed to a failed component.During visual inspection, unrelated to the reported complaint, a cracked/ damaged top cover, holes in the load plate cover, and a damaged front enclosure were observed.The probable root cause for the observed physical damage was user mishandling.The top cover, load plate cover, and front enclosure will be replaced to address the damage.The archive data review showed multiple (ua) 45 error messages, thus, confirming the reported complaint.The autopulse platform failed the initial functional testing due to the (ua) 45 displayed upon powering on, confirming the reported complaint.The integrated encoder gearbox will be replaced to address the observed failure.In addition, the monolithic plunger and belt clip retainer were damaged due to the failed encoder gearbox and will also be replaced.Upon service completion, the console will be subjected to final functional testing to ensure that the device passes all testing criteria.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse platform with sn (b)(6).

Event Description

After patient use, the customer reported the drive shaft of the autopulse platform (sn (b)(6)) could not be returned to the home position and the platform displays a persistent user advisory (ua) 45 (not at "home" position after power-on/restart) error message.The crew reported that emergency room staff may have cut the autopulse lifeband before the platform was turned off.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18379020
• MDR Text Key: 331330178
• Report Number: 3010617000-2023-01054
• 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: 12/21/2023

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: 12/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2020
• 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