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 02/26/2024

Event Type  malfunction  

Event Description

The customer reported the autopulse platform (b)(6) displayed fault code 16 (timeout moving to take-up position) repeatedly.The autopulse lifebands were not twisted.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.

Manufacturer Narrative

The reported complaint that the autopulse platform sn (b)(6) displayed fault code 16 (timeout moving to take-up position) was confirmed during archive review and functional testing.The root cause of the reported complaint was a seized brake gap, due to corrosion/rust on the brake housing area of the drivetrain motor, likely attributed to neglect/user handling.Frequent daily device checks and storing the autopulse in a low humidity location could help prevent the brake gap from seizing.Per the archive, the device was not powered on for more than 9 months before being used.The lack of regular maintenance could lead to degradation of the mechanical components of the drivetrain, including brake seizure.Visual inspection of the returned platform was performed, and no physical damage was observed.Based on archive data, the autopulse platform was last powered on (b)(6) 2024, near the event date.Prior to this date, the platform was last powered on in may 2023.The archive showed fault code 16, thus confirming the reported complaint.Unrelated to the reported complaint, the platform also prompted user advisory (ua) 02 (compression tracking error), (ua) 12 (lifeband not detected), (ua) 20 (drive shaft out of range), and (ua) 23 (compression will exceed 3 revolutions) error messages.The platform failed initial functional testing due to the fault code 16 displayed upon powering up the platform; thus, confirming the reported complaint.It was noticed that there was no brake activation (open/clicking sound) when the platform powered on.The brake assembly was seized from the corrosion preventing the brake from opening or closing during activation.The corrosion was removed by cleaning it with isopropyl alcohol (ipa).After the corrosion was removed, a brake gap inspection was performed, and it was verified that the brake gap was within the specification.The platform was tested with the lrtf (large resuscitation test fixture) for approximately 15 minutes with no issue.The belt switch assembly was verified to be within the specification.The (ua) 02, (ua) 12, (ua) 20, and (ua) 23 seen in the archive could not be reproduced during testing.User advisory is normally a clearable advisory message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the battery hangtag - advisory codes description and action, user advisory 2 is an indication that the autopulse® has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.The recommended actions to take for this type of user advisory are: ensure that the lifeband is properly closed.Pull up completely on the lifeband, ensure that both the patient and the band are properly aligned, and press restart.Per the battery hangtag - advisory codes description and action, user advisory 12 is an indication that the autopulse has detected that the lifeband is not properly installed.The recommended actions to take for this type of user advisory are: ensure that the band clip (underneath the device) is properly seated in the drive shaft can freely rotate after insertion.Per auto pulse user advisory list, user advisory 20 alerts when the drive shaft is not within the specified range of positions.This typically occurs if the autopulse attempted to perform compressions with a cut lifeband installed which allowed the driveshaft to rotate out of operating range.Also, this error message can be triggered due to an internal component error or malfunction.This error message can be cleared by returning the drive shaft to home position using the administrative menu.Per autopulse user advisory list guide, user advisory 23 error message is an indication that the driveshaft will need to travel out of the specified range to get to the calculated compression depth.Typically, this error is an indication of an internal component error or a malfunction.The ua23 error message may be cleared when the user presses restart.Following service, the autopulse platform passed the run-in test without any fault or error.The autopulse platform passed the final testing 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 autopulse platform with serial number (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: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18942299
• MDR Text Key: 339124718
• Report Number: 3010617000-2024-00234
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2023
• 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