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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

The customer reported during a cardiac arrest call, the autopulse platform (sn (b)(6) ) would stop working and advised the crew to realign patient and pull up on the lifeband with every pulse check.Each time the message was displayed, the crew would gently pull up on the lifeband and make sure that the patient alignment was correct.The autopulse platform would continue to work until the next pulse check.The crew stated that they were only able to use the platform for approximately 5 minutes and switched to manual cpr.They did leave the platform under the patient for the duration of the call.The patient was transported to the er for further care.No impact or consequence to the patient due to the device issue.After the call, while troubleshooting the autopulse platform with a training band and mannequin, the board worked until the first pulse check.The autopulse then displayed a message to realign patient and pull up on lifeband.At this point, when hitting the start button, the autopulse would deliver 3 to 10 compressions and stop, advising to realign patient and pull up on the lifeband.They continued to troubleshoot the problem by replacing the battery, lifeband, and realigning the patient multiple times.The autopulse continued to stop after only a few compressions and show the message.After about 10 minutes of troubleshooting the board, fault 27 (encoder fault) was displayed on the screen.The drive shaft was reset to zero/ the home position, but the fault was not cleared.

Manufacturer Narrative

The customer reported complaint that the autopulse platform (sn (b)(6)) would stop working and advised the crew to realign patient and pull up on the lifeband was confirmed during archive data review and functional testing.The reported complaint of fault 27 (encoder fault), noticed by the customer during troubleshooting, was also confirmed during archive review and functional testing.Based on the archive data review, the error message observed by the customer during the patient event was likely to be user advisory (ua) 45 (not at "home" position after power-on/restart) error message and fault 27 (encoder fault).The root cause for the (ua) 45 was due to the drive shaft not being at "home position", likely attributed to unintended user error.The root cause of the fault 27 was due to a failure of the integrated encoder gearbox.During visual inspection, unrelated to the reported complaint, the front enclosure was observed to be damaged, and both head restraint wires on the top cover were heavily frayed and nearly broken off.The damaged head restraints do not render the autopulse platform non-functional.The observed physical damages appeared to be the characteristic of user mishandling.The front enclosure and top cover will be replaced to address the reported complaint.A review of the archive data showed multiple fault 27 and (ua) 45 errors: thus, confirming the reported complaint.The autopulse platform failed initial functional testing due to the displayed fault 27 (encoder fault), confirming the reported complaint.The integrated encoder gearbox will need to be replaced to remedy the fault code.Also, unrelated to the reported complaint, a sticky clutch was found.The impact of a sticky clutch was not severe enough to make the platform non-functional.The cause for the sticky clutch could be due to normal wear and tear.The clutch plate will be deburred to address the observed problem.The (ua) 45 observed in the archive was not reproduced.User advisory 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 (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.Upon service completion, the platform will be subjected to final functional testing to ensure that the device passes all testing criteria.Historical complaints were reviewed for service information related to the reported issue and there were no similar complaints reported for autopulse platform with sn (b)(6).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18938055
• MDR Text Key: 338201270
• Report Number: 3010617000-2024-00219
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• 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