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

Model Number MODEL 100

Device Problem Intermittent Loss of Power (4016)

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

Event Date 02/08/2023

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(4)) powered off unexpectedly after 15 minutes of use was confirmed during functional testing and archive data review.The root cause of the reported complaint was the battery connector cable failure, likely attributed to the age of the platform.The autopulse platform was manufactured in 2012 and is 11 years old, past beyond the expected serviceable life of 5 years.Upon visual inspection, unrelated to the reported complaint, noted a connector pin broke off from the processor distribution board (pdb), likely attributed to the age of the platform.The pdb was replaced to address the observed damaged pin.Data archive showed three "battery lost" failures on (b)(4) 2022, thus confirming the reported complaint.Also, unrelated to the reported complaint, (b)(4) (compression tracking error), (b)(4) (load imbalance between left and right sides of the load plate) errors.The load cell characterization check was performed, and both load cells functioned within the specification.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 02 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 indicates that the patient/manikin is out of position, or the patient/manikin is not correctly centered.The recommended actions to take for this type of user advisory are: ensure the patient/manikin is aligned correctly (armpits on the yellow line), deploy the shoulder restraint to reduce patient/manikin movement, and press restart to clear the ua.The autopulse platform failed initial functional testing due to to sudden power loss during compression, thus confirming the reported complaint.The root cause of the reported complaint was the battery connector cable, and it was replaced.Following service, the brake gap inspection was performed and verified the brake gap was within the specification.The autopulse platform passed the final run-in test without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for the autopulse platform with sn (b)(4).

Event Description

During patient use, the autopulse platform (sn (b)(4)) powered off unexpectedly after 15 minutes of use.The customer then restarted the autopulse platform, and it worked fine for a short period, and then powered off again.Per reporter, the battery was replaced but issue persited.The customer reverted to manual cpr.No consequences or impact to the patient.

• 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: 16469515
• MDR Text Key: 310545040
• Report Number: 3010617000-2023-00215
• 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: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2012
• 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