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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Physical Resistance/Sticking (4012)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the lifeband got stuck in the platform's driveshaft and couldn't be removed was not confirmed during functional testing.The reported complaint that the autopulse platform displayed user advisory 45 (not at "home" position after power-on/restart) after removing the lifeband was confirmed in the archive data, but it was not confirmed during functional testing.The root cause of the ua45 advisory message was due to the driveshaft not being at the "home" position due to unintended user error.Before sending the platform to zoll for service, the encoder driveshaft had been rotated back to its "home" position, and the ua45 had been cleared.Visual inspection of the returned autopulse platform showed no physical damage.The archive data review indicated multiple ua45 advisory messages around the reported event date, confirming the customer's reported complaint.A 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 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 autopulse platform passed the initial functional test without any fault or error.A known-good lifeband was installed in the autopulse platform, and the platform performed compressions without issues.The customer initially stated that the autopulse platform made an unusual sound during use, but during functional testing, the platform performed as intended without making any unusual sound.The test lifeband was able to be easily removed from the platform.Unrelated to the reported complaint, it was noted that the drivetrain motor brake gap was too wide, out of specification.The brake gap needs to be adjusted within the specification to resolve the issue.Zoll is awaiting the customer's approval for repair.

Event Description

The customer reported hearing an unusual sound from the autopulse platform (sn (b)(6)) during patient use.Despite the sound, compressions did not stop, the platform continued to be used, and there were no adverse consequences for the patient.After patient use, the customer tried to remove the lifeband but encountered difficulty pulling it up to remove it.The lifeband got stuck in the platform's driveshaft, preventing its easy removal.To address the issue, the customer cut the lifeband with scissors to free it from the driveshaft.Subsequently, the lifeband was successfully removed from the platform.After removing the lifeband, the autopulse platform displayed user advisory 45 (not at "home" position after power-on/restart).Zoll tech support provided instructions to the customer on how to clear the ua45 advisory message.Following zoll's guidance, the customer successfully cleared the ua45 advisory message.No patient involvement.

• 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 thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18271592
• MDR Text Key: 329807930
• Report Number: 3010617000-2023-01007
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• 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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2022
• 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