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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

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

Event Date 10/12/2023

Event Type  malfunction  

Event Description

During a call, the autopulse platform (b)(6) stopped working and displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message after 29 minutes of compressions.The crew was unable to get the unit to restart again.Manual cpr was performed for about 2 minutes.The 79-year-old female patient did not survive, but the crew does not believe the device contributed to the patient death.The patient was pronounced at henry form macomb in clinton township, michigan by dr.Dimichele.A lot of fluids were involved in the event, but the crew had a hygiene barrier in place.The device was completed deconned and cleaned after the event.When testing the device, it would not initialize and showed (ua) 07.

Manufacturer Narrative

The reported complaint that the autopulse platform (b)(6) stopped working and displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message was confirmed during functional testing and review of the archive data.The root cause of the (ua) 07 was due to the failure of single point load cell module 2.The cracked cover and load cell failure were likely attributed to mishandling, such as a drop.During visual inspection, unrelated to the reported complaint, the front cover was observed to be cracked in the front-end area.The observed physical damage was unrelated to the reported complaint and appeared to be the characteristics of mishandling.The front cover was replaced to address the issue.A review of the archive data showed (ua) 07 error messages; thus, confirming the reported complaint.The platform failed initial functional testing due to the (ua) 07 advisory message displayed upon powering up the platform; thus, confirming the reported complaint.The load sensing system has detected a weight/load imbalance between the two load cells.Load cell characterization result indicated single point load cell module 2 was over reporting, which will affect the linearity of the two load cells installed in the autopulse platform.Single point load cell module 2 was replaced to remedy the 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 were no similar complaints reported for autopulse platform with serial number (b)(6).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 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 does not start or unexpectedly stops compressions, the 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 patient's 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: 18066509
• MDR Text Key: 327301340
• Report Number: 3010617000-2023-00943
• 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: 11/03/2023

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: 10/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2019
• 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
• Patient Age: 79 YR
• Patient Sex: Female