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

Model Number MODEL 100

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184); Noise, Audible (3273)

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

The customer reported during patient use, the display screen of the autopulse platform (sn (b)(6) was initially scrambled, then displayed only two lines across the screen.Once the display stopped flashing, a clicking sound was observed from the display.No user advisories were displayed.The crew switched to manual cpr immediately.Manual cpr was performed for over half an hour.The customer reported the patient died, but not due to the autopulse failure.

Manufacturer Narrative

The reported complaint that the display screen of the autopulse platform (sn (b)(6) was initially scrambled, then displayed only two lines across the screen with a clicking sound was confirmed during functional testing.The likely root cause was a failure of the processor pca board, possibly related to the age of the device.The autopulse platform was manufactured in august 2017, and is nearly 7 years old, past its expected service life of 5 years.Upon visual inspection, unrelated to the reported complaint, a twisted battery clip, bent battery spring guide, broken screw well that holds down battery spring (top cover), and damaged front and bottom enclosure were observed.The observed physical damages appeared to be the characteristic of user mishandling.The top cover, front and bottom enclosure, battery clip, and battery spring guide were replaced to address the issues.A review of the archive data showed system error - 132 (internal watchdog timeout) and user advisory (ua) 16 (timeout moving to take-up position) error message, unrelated to the reported complaint.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering on, unrelated to the reported complaint.After clearing the system error, scrambling on the display screen started to occur, thus, confirming customer complaint.The attempt to re-install firmware was unsuccessful.The processor board was replaced to remedy both problems.During inspection of the brake gap, the brake gap was open to 0.013" and was out of specification.The drive train motor was be replaced to remedy the brake gap issue, and to prevent future occurrences of error messages of (ua) 16, as observed in the archive.The device was tested with an instrumented manikin and lrtf (large resuscitation test fixture) for approximately 15 minutes each with no issue.Following service, the autopulse platform passed the run-in test without any fault or error.The autopulse platform passed the 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 34020.The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr, adjunctive use only indication is prominently displayed on device labels and in the device manual.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions when effective manual cpr is not possible.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.The autopulse is intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the trained user reverts to manual cpr.The transition from autopulse to manual cpr by trained users is similar to the time necessary for rescuer rotation and presents the same workflow as manual cpr.Hence, based on available information, the patients' outcome was not negatively impacted by the interruptions when compared to standard of care manual cpr.Out-of-hospital cardiac arrest (ohca) is one of the main causes of death in industrial nations.About 25% of patients survive this event and make it to the hospital, and even fewer patients survive after 24 hours (nichol, nejm, 2015).In the united states, survival to hospital discharge after non-traumatic emergency medical services-treated cardiac arrest with any first recorded rhythm was 10.6% for patients of any age.Of the bystander-witnessed out-of-hospital cardiac arrests in 2011, 31.4% of victims survived to hospital discharge (mozaffarian, circulation, 2016).Death is an expected outcome for ohca.

• 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: 18697577
• MDR Text Key: 336510078
• Report Number: 3010617000-2024-00108
• 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
• Report Date: 02/13/2024

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: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2017
• 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