MAUDE Adverse Event Report: ZOLL CIRCULATION 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 Type  malfunction  

Event Description

As reported, the autopulse platform sn (b)(6) would not start compressions after displaying the message "to realign the patient and press the start button." in addition, the platform was reporting the user advisory (ua) 45 (not at "home" position after power-on/restart) error message.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.

Manufacturer Narrative

The device associated with this complaint has been received, however, the investigation is pending.A follow-up report will be filed when the investigation has been completed.B3, the date of event is unknown.

Manufacturer Narrative

The customer's reported complaint of the autopulse platform (sn (b)(6) ) displayed user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message was confirmed during initial functional testing and archive data review.The root cause for the (ua) 45 error message was due to the driveshaft not being at home position, which is likely attributed to user error.The autopulse functioned as intended by triggering (ua) 45 when the driveshaft is not at "home" position.User advisory (ua) 45 is a clearable error message; per the autopulse® resuscitation system model 100 user guide, if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory (ua) 45 pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.During visual inspection of the platform, both of the head restraint wires on the top cover were observed frayed.The damaged or cut head restraints do not render the autopulse platform non-functional.The head restraint wire could have been cut to free the patient from the platform, or the user could have been lifting the platform by holding the head restraints, likely due to user mishandling.The top cover was replaced to remedy the damage.Further visual inspection revealed, unrelated to the reported complaint, that the encoder drive shaft does not rotate smoothly and exhibits binding and resistance.The root cause was the sticky driveshaft clutch area, usually caused by sharp edges from all 12-hex edges of the armature plate or burrs on the clutch rotor's surface, likely attributed to normal wear and tear.The sticky clutch's impact was not severe enough to make the platform non-functional.The clutch plate was deburred to remedy the problem.The autopulse platform was manufactured in (b)(6) 2013 and is almost 11 years old, beyond its expected service life of 5 years.The archive data review showed a user advisory (ua) 45 error message around the reported complaint date, thus confirming the reported complaint.In addition, unrelated to the reported complaint, the archive data indicated (ua) 02 (compression tracking error) message that was cleared by the user.User advisory is normally a clearable error message and is designed into the autopulse platform to alert the operator that autopulse has detected one of several conditions.Per the battery hangtag - advisory codes description and action, user advisory 02 is an indication that 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.During functional testing, a user advisory (ua) 45 error message was displayed upon powering up the platform, thus confirming the reported complaint.The driveshaft was rotated to the home position to clear the user advisory (ua) 45 error message.However, the platform failed to achieve take-up and inability to perform compression, and displayed a fault code 29 (loss of brake connectivity), unrelated to the reported complaint.Investigation revealed a failed pdb.The pdb was replaced to remedy the fault.Following service, the brake gap inspection was performed and verified the brake gap was within the specification.A load cell characterization test was performed and confirmed that both cell modules function within the specification.The autopulse platform passed the run-in and final tests without fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 18975670
• MDR Text Key: 338683003
• Report Number: 3010617000-2024-00246
• 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,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2013
• 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