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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported during patient use, the autopulse platform (b)(6) displayed fault 16 (timeout moving to take-up position).The crew switched the patient to another autopulse platform on another vehicle that arrived later.No additional information was provided.Patient's status information was requested but the customer did not provide a response.

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(6)) displayed fault 16 (timeout moving to take-up position) was confirmed based on the review of the archive data and during functional testing.The root cause of the reported complaint was related to the failure of the drive train motor, possibly attributed to wear and tear.The autopulse platform was manufactured in 2019 and has nearly reached its expected serviceable life of 5 years.During visual inspection, cracks were observed in the front-end area of the front cover, the screw well area of the bottom cover, and the left channel roller area on the top cover.The observed physical damages are unrelated to the reported complaint and appeared to be the characteristic of user mishandling.The front, bottom, and top covers will be replaced to address the damage.Based on archive data review, multiple fault 16 were observed around the event date, thus, confirming the reported complaint.The autopulse failed to achieve the target depth for take-up within the specified time of around 5 seconds due to a defective drive train motor (slipped bushing).Whenever the bushing slips, the drive train motor seizes and becomes unable to rotate.The autopulse platform failed initial functional testing due to fault 16, thus, confirming the reported complaint.Upon inspection, it was verified that the brake gap was within the specification of 0.008" ±0.001".The root cause of the device failing to achieve take-up and not performing compressions, resulting in the displayed fault 16, was related to the failed drive train motor.The drive train motor will be replaced to remedy the complaint.Unrelated to the reported complaint, the platform failed the load cell characterization test.Both single point load cells were over-reporting and will need to be replaced.The cracked covers and load cells failure were likely attributed to mishandling such as a drop.Upon service completion, the platform 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 were no similar complaints reported for autopulse platform with sn (b)(6).

• 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: 18813465
• MDR Text Key: 336789916
• Report Number: 3010617000-2024-00169
• 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,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2019
• 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