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

Model Number 8700-0701-01

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

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

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the lifeband for investigation.A supplemental report will be filed when the product is returned and the 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, when the autopulse platform ((b)(4)) used on a cardiac arrest patient, the life band was broken.Crew reverted to manual cpr immediately.The patient was pronounced dead and the customer didn't attribute the death to using the device.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.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 ((b)(6) 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.Please see the following related mfr report: mfr # 3010617000-2018-01251 for the autopulse platform.

Event Description

As reported, while using the autopulse platform ((b)(4)) on a patient with cardiac arrest, the life band appeared to be broken.The crew reverted to manual cpr.However, the patient was pronounced dead.According to the crew, the patients death was not related to the autopulse platform.The crew disposed the life band.

• 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: 8151741
• MDR Text Key: 130079605
• Report Number: 3010617000-2018-01252
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8700-0701-01
• Device Catalogue Number: 8700-0701-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2018
• 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