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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During training, after the customer paused the loaner autopulse platform (sn (b)(6) , the lifeband was unable to be pulled up when attempting to resume.When the customer pressed the start/continue button, the lifeband was pulled up, but the platform didn't restart compressions.When the customer pressed the start/continue button again, the platform finally restarted compressions.No patient involvement.Zoll sales representative tested the autopulse platform with another lifeband in the hospital.After several attempts to test the platform, the claimed issue was replicated once.
Additional Manufacturer Narrative
The reported complaint was confirmed during both archive data review and functional testing.The root cause of the reported issue was that the platform's driveshaft was not rotating smoothly, exhibiting binding and resistance due to having a sticky clutch plate.The sticky driveshaft clutch area is usually caused by sharp edges of the armature plate or burrs on the surface of the clutch rotor.Visual inspection of the returned autopulse platform showed no apparent physical damage.A review of the archive data showed multiple user advisory (ua) 07 (discrepancy between load 1 and load 2 too large), ua45 (not at "home" position after power-on/restart), and ua02 (compression tracking error) around the customer's reported event date, unrelated to the reported complaint.These advisories were cleared by the user and were not replicated during functional testing.User advisory is normally a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse maintenance guide and autopulse user advisory list, user advisory 07 occurs when the load sensing system has detected a weight/load imbalance between the two load cells.The device does not need to be performing compressions for this to occur; it may happen at any time when the device is powered on.User advisory 07 is an indication that the patient (or test manikin) is out of position, or the patient is not properly centered.The recommended actions to take for this type of user advisory are: ensure the patient is properly aligned (armpits on the yellow line), deploy the shoulder restraint to reduce patient movement and press restart to clear the ua.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 (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.Per the battery hangtag - advisory codes description and action, user advisory 2 is an indication that autopulse® has not 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 or jammed 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, the autopulse platform powered up with no advisories or faults.The driveshaft clutch area was found to be sticky, causing the intermittent issue reported by the customer.The clutch plate will be deburred to remedy the problem.Zoll is awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse platform with serial number (b)(6).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: 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: 18628582
• Report Number: 3010617000-2024-00080
• Device Sequence Number: 7763247
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown