MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LIFEBAND; CHEST COMPRESSION ASSEMBLY

Model Number 8700-0701

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2018

Event Type  malfunction  

Manufacturer Narrative

The autopulse 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.In this case, the lifeband was unable to retract during the deployment state in a cardiac arrest patient.Since it was difficulty to remove the lifeband for replacement, the user cut the lifeband and reverted to manual cpr immediately.After an unspecified amount of time, the patient achieved pulse and was transferred to the hospital emergency room (er).The patient subsequently expired at the er.The autopulse was intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the 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.Mortality of out-of-hospital cardiac arrest (ohca) is high.Survival to hospital discharge, after ems-treated non-traumatic cardiac arrest with any first recorded rhythm was 9.8% for adults (aha statistical update 2013).In this event, death is attributed to ohca.Death is an expected outcome for ohca.

Event Description

During the deployment state, the user positioned the patient (in cardiac arrest) on the autopulse platform (sn (b)(4)) and placed the lifeband on the patient's chest; however, the user observed that the lifeband was unable to retract.The user attempted to replace the lifeband but experienced difficulty during removal.The user cut the lifeband and removed the patient off the platform.Manual cpr was immediately performed for an unspecified amount of time until the patient achieved pulse.The length of troubleshooting was not specified.The patient was transported to the hospital and care was transferred to the emergency room (er).It was further reported that the patient subsequently expired at the er.This references the report of the lifeband unable to retract.The report of the platform unable to provide compression is referenced under mfr 3010617000-2018-00291.

• Brand Name: AUTOPULSE® LIFEBAND
• Type of Device: CHEST COMPRESSION ASSEMBLY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7356204
• MDR Text Key: 103288188
• Report Number: 3010617000-2018-00292
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8700-0701
• Device Catalogue Number: 8700-0701
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR