MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE LIFEBAND; CARDIAC RESUSCITATOR BAND

Model Number MODEL 100

Device Problems Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

The lifeband used at the time of the event will not be returned for evaluation, as it was discarded by the customer.Therefore, a physical investigation could not be performed and a root cause could not be determined.

Event Description

An autopulse platform was deployed for resuscitating a patient in cardiac arrest.The customer reported that the new material of the autopulse lifeband (lot # unknown) is too soft, causing the lifeband to be more likely twisted around itself, on the autopulse edges, while trying to be installed on the autopulse platform.The customer stated that the reported issue causes the autopulse driveshaft to get stuck upon turning on.When the green start/continue button was pressed, the autopulse platform failed to size the patient and displayed user advisory ua17 (max motor on time exceeded during active operation).The customer tried to clear the ua17 advisory message by pulling up the lifeband; however, the issue persisted.The customer replaced the lifeband, and the issue was resolved.Per the customer, the autopulse platform has been working as intended.The patient's status information was requested, but the customer did not provide a response.

Manufacturer Narrative

According to available information, the death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions.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

An autopulse platform was deployed for resuscitating a patient in cardiac arrest.The customer reported that the new material of the autopulse lifeband (lot # unknown) is too soft, causing the lifeband to be more likely twisted around itself, on the autopulse edges, while trying to be installed on the autopulse platform.This issue causes the autopulse driveshaft to get stuck upon turning on.When the green start/continue button is pressed, the autopulse platform fails to size the patient and display the user advisory ua17 (max motor on-time exceeded during active operation).The customer tried to clear the ua17 advisory message by pulling up the lifeband; however, the issue persisted.Return of spontaneous circulation (rosc) was not achieved, and the patient was pronounced dead.No further information is available at this time.The customer did not provide information regarding the relationship between the death and the alleged malfunction.However, the msa evaluated the incident, and it was determined that the death was not related to the autopulse device.The customer replaced the lifeband, and the issue was resolved.Per the customer, the autopulse platform is working as intended.Please see the following related mfr report: mfr #3010617000-2021-00976 for the autopulse platform.

• Brand Name: AUTOPULSE LIFEBAND
• Type of Device: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 12559384
• MDR Text Key: 274247532
• Report Number: 3010617000-2021-00961
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

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: 8700-0701-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1