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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2023

Event Type  malfunction  

Event Description

After the patient call, the customer was unable to rotate the drive shaft of the autopulse platform (sn (b)(6) to the home position and replace the lifeband.No patient involvement.

Manufacturer Narrative

The reported complaint of the driveshaft of the autopulse platform (sn (b)(6) will not rotate to the home position was confirmed during the functional testing and archive review.The root cause of the reported complaint was a failed integrated encoder gearbox and the plunger shaft lock due to a defective component, likely attributed to normal wear and tear.The autopulse platform was manufactured in october 2016 and is over 7 years old, beyond its expected service life of 5 years.Visual inspection of the returned autopulse platform was performed and revealed the top cover, front, and bottom enclosures were cracked.The observed physical damages were unrelated to the reported complaint and appeared to be the characteristics of harsh impact due to user mishandling.The top cover, front, and bottom enclosures were replaced to address the observed damages.The archive data review showed (ua) 45 (driveshaft not at "home" position after power-on/restart) error message around the reported event date, thus confirming the customer complaint that the driveshaft will not rotate to the home position.In addition, not related to the reported complaint, a (ua) 17 (max motor on time exceeded during active operation) and fault code 28 (loss of clutch connectivity) error messages occurred around the customer's reported event date.The errors were cleared by the customer and were not duplicated during the platform testing.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 17 is an indication that the lifeband is twisted, or battery voltage is low.The recommended actions to take for this type of user advisory are: open lifeband, start manual cpr, check battery and lifeband, pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.Per autopulse user advisory list, fault code 28 alerts when the brake and clutch monitoring circuit detect 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 failed functional testing due to (ua) 45 displayed upon powering on.The (ua) 45 message is related to the customer-reported complaint because the autopulse platform triggers (ua) 45 when the driveshaft is not at its 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, the driveshaft was found to be stuck in one position and nearly impossible to move, thus, confirming the customer's reported complaint.The encoder gearbox and the plunger shaft lock were replaced to remedy the problem.The device subsequently passed a 15-minute functional run-in test with the large resuscitation testing fixture (lrtf) equivalent to a 250-pound patient.Following service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18407207
• MDR Text Key: 331689235
• Report Number: 3010617000-2023-01093
• 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: 12/27/2023

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
• 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: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2016
• 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