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

Model Number MODEL 100

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2020

Event Type  malfunction  

Manufacturer Narrative

The lifeband in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed if the product is returned and investigation has been completed.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 was 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

The autopulse platform (sn: (b)(4)) was used to resuscitate a (b)(6) old male patient in cardiac arrest.It is unknown if the cardiac arrest was witnessed, and the cause was unidentified.It is unknown what the duration of the patient's cardiac arrest was before the patient received manual cpr, which was performed for 14 minutes prior to the use of the autopulse platform.When the autopulse was powered on, the platform failed to perform compressions as the lifeband would not size the patient.During troubleshooting, it was noted that the lifeband was twisted on one side.The customer did not provide further information, and it is unknown whether manual cpr was performed or not after the issue was observed.Return of spontaneous circulation (rosc) was not achieved, and the patient was pronounced dead on the scene.As per the customer, it is unknown if the patient's death was related to the autopulse system.Please see the following related mfr report: mfr # 3010617000-2020-00584 for the autopulse platform (sn: (b)(4)).

Event Description

The autopulse platform (sn: (b)(6) ) was used to resuscitate a 65-year-old male patient in cardiac arrest.It is unknown if the cardiac arrest was witnessed, and the cause was unidentified.It is unknown what the duration of the patient's cardiac arrest was before the patient received manual cpr, which was performed for 14 minutes prior to the use of the autopulse platform.When the autopulse was powered on, the platform failed to perform compressions as the lifeband would not size the patient.During troubleshooting, it was noted that the lifeband was twisted on one side.The customer did not provide further information, and it is unknown whether manual cpr was performed or not after the issue was observed.Return of spontaneous circulation (rosc) was not achieved, and the patient was pronounced dead on the scene.As per the customer, it is unknown if the patient's death was related to the autopulse system.Please see the following related mfr reports: ccr 49760, mfr # 3010617000-2020-00584 for autopulse platform.Ccr 49758, mfr # 3010617000-2020-00581 for patient 1.Ccr 49759, mfr # 3010617000-2020-00582 for patient 2.Ccr 49483, mfr # 3010617000-2020-00502 for patient 4.

Manufacturer Narrative

B5 (describe event or problem) was updated.

• Brand Name: AUTOPULSE LIFEBAND
• Type of Device: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10126250
• MDR Text Key: 194333526
• Report Number: 3010617000-2020-00585
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

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?: Yes
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR