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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

Event Description

During the patient call, the autopulse platform (b)(6) displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) error message upon powering on and the error could not be cleared.The patient was not on the autopulse platform.Manual cpr was performed.No consequences or impact to the patient.

Manufacturer Narrative

The reported complaint that the autopulse platform (sn (b)(6) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) was confirmed during the archive data review and functional testing.The root cause of the ua45 advisory message was that the driveshaft was not in "home" position, most likely attributed to unintended user error.Upon visual inspection, unrelated to the reported complaint, noted the cracked top cover and front enclosure.The probable root cause for the observed physical damages could be due to user mishandling, such as a drop.The top cover and front enclosure were replaced to address the observed physical damages.During further inspection, the clutch plate was found sticky, unrelated to the reported complaint.This is usually caused by sharp edges from all 12-hex edges of the armature plate, or due to burrs on the surface of the clutch rotor.The impact of the sticky clutch was not severe enough to make the platform non-functional.The clutch plate was replaced to remedy the issue as it was deburred in 2021 under the previous return of service.The archive data show the presence of a user advisory (ua) 45 error message around the customer's reported date that likely related to the drive shaft was not in the home position during the power on, thus confirming the reported complaint.Unrelated to the complaint, the archive also showed (ua) 12 (lifeband not present) and (ua) 07 (discrepancy between load 1 and load 2 too large) messages.The error messages were cleared by the user and were not reproduced during the functional testing.User advisory is normally a clearable error message and is designed into the autopulse platform to alert the operator that the platform has detected one of several conditions.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.The user advisory 12 is an indication that autopulse platform 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 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/manikin is out of position, or the patient/manikin is not properly centered.The recommended actions to take for this type of user advisory are: ensure the patient/manikin is properly aligned (armpits on the yellow line), deploy the shoulder restraint to reduce patient/manikin movement, press restart to clear the ua.Functional evaluation failed as the autopulse platform displayed a (ua) 45 advisory message upon powering up, confirming the reported complaint.The driveshaft was rotated to the "home" position to remedy the fault.Following the 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 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: kim sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18919229
• MDR Text Key: 337854745
• Report Number: 3010617000-2024-00228
• 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: 03/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2024
• 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: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• 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