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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse platform sn (b)(6) displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) was confirmed in the archive data and during functional testing.The root cause of the ua45 advisory message was that the driveshaft was not in "home" position, most likely attributed to unintended user error.Visual inspection of the autopulse platform revealed that the front enclosure was cracked at the front-end area, unrelated to the reported complaint.The observed physical damage appeared as characteristic of harsh impacts due to user mishandling.The damaged enclosure was replaced to address the issue.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 it 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.A preliminary functional test failed as the autopulse platform displayed a ua45 advisory message upon powering up, confirming the reported complaint.The driveshaft was rotated to "home" position to remedy the ua45 advisory message.Subsequently, the platform was tested with the large resuscitation test fixture (lrtf) with known good test batteries until discharged without any fault or error.Following service, the autopulse platform was subjected to a final run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged 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 reported for the autopulse platform with serial number (b)(6).

Event Description

During patient use, the autopulse platform sn (b)(6) displayed a user advisory (ua) 45 (not at "home" position after power-on/restart).The crew pulled up the lifeband and tried to re-adjust it several times, but the issue was not resolved as the lifeband would not reset.The crew replaced the lifeband, but the ua45 advisory persisted.The crew did not use the autopulse platform, and manual cpr was initiated.No consequences or impacts on the patient.The customer stated that the autopulse platform was functioning as intended during shift checks.

• 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: 18665076
• MDR Text Key: 334846856
• Report Number: 3010617000-2024-00120
• Device Sequence Number: 1
• Product Code: DRM
• 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: 02/07/2024

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: 01/26/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2021
• 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