MAUDE Adverse Event Report: ZOLL CIRCULATION INC 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 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse platform sn (b)(6) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) message was confirmed during the archive review and functional testing.The root cause for the (ua) 45 error was due to the driveshaft not being at "home position".Visual inspection of the returned platform was performed, and no physical damage was observed.A review of the archive data showed multiple (ua) 45 errors on the event date, thus, confirming the reported complaint.Usually, the error message can be cleared by pulling up the lifeband until the chest bands are fully extended to move the driveshaft to its home position.However, in this case, the encoder drive shaft was not within the normally acceptable range.To clear the (ua) 45, the customer would need to access the admin menu and manually rotate the drive shaft to the home position.The platform failed functional testing due to the (ua) 45 displayed upon powering up the platform.The admin menu was accessed, and the encoder shaft was manually rotated to the "home" position to remedy the error message.Subsequently, the platform was tested with the large resuscitation test fixture (lrtf) with good known test batteries until discharged without fault or error.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 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 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.

Event Description

During patient use involving a 67-year-old 67 kg male patient with a history of diabetes, the customer reported the autopulse platform sn (b)(6) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) message immediately.The platform was unable to perform any compressions.The customer followed instructions according to the user manual to troubleshoot the error message.The crew tried to reset the drive shaft to the home position multiple times, but the error would reappear after every clearance attempt.Manual cpr was performed by family prior to arrival.Manual compressions were used and continued on scene with the medics, throughout transport, and transfer of care.The call was dispatched at 8:30 and the time of transfer to ed was 8:59.The customer reported a total of 29-35 minutes of manual cpr.The patient did not achieve rosc (return of spontaneous circulation), and he was down for a short period of time.The patient as pronounced at the hospital.Per the customer, they believe that the patient would have survived with the use of an automatic chest compression device (accd).However, the msa evaluated the incident and it was determined that the death was not related to the autopulse device.

• 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: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19006037
• MDR Text Key: 339252629
• Report Number: 3010617000-2024-00265
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2019
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 67 KG