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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2024

Event Type  malfunction  

Event Description

The autopulse platform (sn (b)(6) displayed a user advisory (ua) 20 (position out of range) error message.No additional information was provided.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.

Manufacturer Narrative

The reported complaint that the autopulse platform (sn (b)(6)) displayed a user advisory (ua) 20 (position out of range) error message was confirmed during the archive data review and functional testing.The root cause of (ua) 20 was that the drive shaft was rotated out of operating range.The (ua) 20 message usually can be 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, a seized brake gap on the cabled drive train was observed, preventing the drive shaft from rotating to the home position.The root cause of the seized brake gap is likely attributed to user maintenance.A review of the archive data revealed that frequent daily checks were not performed by the customer, and the storage condition of the platform is not known.Frequent daily device checks and storing the autopulse platform in a low humidity location could help prevent degradation of the mechanical components of the drive train, including brake seizure.During visual inspection, no physical damage was observed on the platform.A cut autopulse lifeband was connected to the returned platform, possibly related to the reported complaint.It is likely the customer was unable to remove the lifeband due to the seized brake gap.The lifeband was removed to remedy the issue.A review of the archive file showed the autopulse platform displayed multiple (ua) 20 error messages on the reported event date, thus, confirming the reported complaint.Unrelated to the reported complaint, multiple user advisory (ua) 07 (discrepancy between load 1 and load 2 too large), (ua) 12 (lifeband not present), (ua) 17 (motor on for too long during active operation), and (ua) 45 (drive shaft not at home position) error messages and one warning 01 (low battery warning) and (ua) 02 (compression tracking error) message were also observed on the complaint date.The autopulse platform failed initial functional testing due to (ua) 20, thus, confirming the reported complaint.To remedy the error message, ipa was used to clean the brake housing area and the drive shaft was rotated to the home position.Unrelated to the reported complaint, a sticky clutch plate was observed.The cause for the sticky clutch could be due to normal wear and tear.The clutch was deburred to address the observed problem.The warning 01, (ua) 02, (ua) 07, (ua) 12, (ua) 17, and (ua) 45 observed in the archive were not reproduced.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 autopulse user advisory list, warning 01 is an indication that the battery has less than 5 minutes of active operation left before battery is too low to operate, and the battery needs to be replaced and placed into the multi-chemistry charger.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.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.Per the battery hangtag - advisory codes description and action, user advisory 12 is an indication that the autopulse 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 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 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.During servicing, the autopulse platform failed the load cell characterization test, unrelated to the reported complaint.Both single point load cells failed, likely attributed to failed component(s), or mishandling such as a drop.Both load cells were replaced to remedy the issue.Subsequently, the platform passed the load cell characterization test, run-in test, and final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints 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: 18899762
• MDR Text Key: 337689563
• Report Number: 3010617000-2024-00203
• 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: 03/13/2024

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
• 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: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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