MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION; 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 02/11/2024

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse platform (sn (b)(6)) displayed a user advisory (ua) 18 (max take-up revolution exceeded) error message was confirmed based on the archive data review but was not confirmed during the functional testing.The autopulse platform passed the testing and performed as intended.The probable root cause of the reported user advisory (ua)18 error was either the patient's chest was too small while sizing the patient (take-up) or that there was no patient on the platform.The returned autopulse platform was visually inspected, and no physical damage was observed.The archive data review showed multiple (ua) 18 error messages to have occurred on the customer's reported event date, thus confirming the reported complaint.In addition, unrelated to the reported complaint, further review of the archive data indicated multiple (ua) 02 (compression tracking error), (ua) 45 (not at "home" position after power-on/restart) error messages, and the fault code 29 (loss of brake connectivity).All error messages were cleared by the customer, and they were not reproduced during the functional testing.User advisory is a clearable message designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse hangtag - advisory codes description and action, user advisory 18 is an indication that the autopulse® has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.The recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.If the user advisory does not clear, the patient may be too small.In this case, revert to manual cpr.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.The autopulse platform failed functional testing due to (ua) 45 displayed upon powering on and noted a stuck driveshaft during the internal inspection, unrelated to the reported complaint.The root cause for the (ua) 45 error was the drive shaft not being at the "home position." the (ua) 45 error message can be easily cleared by pulling up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its home position.However, in this case, noticed a stuck driveshaft.The clutch was deburred to address the driveshaft issue and then the driveshaft was rotated to the "home position" to address the observed (ua) 45 message.Per the autopulse user advisory list, fault code 29 alerts when the brake and clutch monitoring circuit detects a loss of connectivity on the brake driving circuit.This typically occurs if there is an internal component error or malfunction.If no internal component failure is detected, this error message can be cleared when the user presses restart.The autopulse platform passed the initial functional test without any fault or error, unable to replicate the customer's reported complaint.During further testing, unrelated to the reported complaint, a worn clutch plate was noted, likely attributed to normal wear and tear.The clutch plate was replaced as a precautionary measure to remedy the issue.Following the service repair, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.

Event Description

During patient use, the customer reported that the autopulse platform (sn (b)(6)) displayed a user advisory (ua) 18 (max take-up revolutions exceeded) error message.The ua only temporarily delayed cpr; after the user tried to reposition the patient several times, manual cpr was carried out.No impact or consequence to the patient.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18853053
• MDR Text Key: 337074076
• Report Number: 3010617000-2024-00190
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2020
• 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