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

Model Number 8700-0701

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Contusion (1787); Injury (2348)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

Zoll has not yet received the autopulse lifeband in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.The death was not related to the autopulse device.Patient died the following day after rosc achieved with the device.The cause of death was due to worsening of the primary disease, which is heart disease that caused cardio-pulmonary 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

It was reported that on the autopulse platform, the lifeband (s/n (b)(4)) malfunctioned.After approximately 20 minutes of device compression activation, the lifeband got snagged on one side and failed to extend (i.E., remained in a contracted state).However, the autopulse platform continued to work without issuing any error messages.The patient was an (b)(6) female, weighing (b)(6).The patient had a history of high blood pressure.After taking a bath the patient began to wheeze.A family member made the emergency call.The patient suffered a cardiopulmonary arrest during the time between the emergency call and the emergency crew's arrival.Bystander cpr was administered by a family member(s).The autopulse platform was used once the emergency crew arrived at the scene.After 20 minutes the reported event occurred.The autopulse continued to perform compressions for another 32 minutes during transporting the patient to the er.The patient arrived at the er without an lt (laryngeal mask), as the patient's breathing was fine with a bvm (bag valve mask).The patient's heart began to beat again within 1-2 minutes after she arrived at the hospital.Autopulse was discontinued after rosc.At some point, after the patient arrived at the hospital bleeding from the mouth was observed.It was noted that when the patient arrived at the er, bleeding inside the mouth was not found.Additionally, artificial breathing was administered after being admitted to the hospital, but bleeding resulting from the intubation tube was not observed.No injury inside the mouth cavity or pharynx was found.It is uncertain how and why the patient was bleeding from the mouth.Abrasion was seen in the area covering the lower part of the chest to the upper abdominal area.This abraded wound is thought to be caused by the lifeband.X-ray ct found rib fractures of right - 4th rib and left - 5th, 6th, 7th, and 8th ribs.These rib fractures were thought to be caused by cpr; however, it could not be determined whether they were a result of manual cpr or the use of autopulse.The rib fractures are not considered serious enough to affect the patient's prognosis.Cpr commonly results in a rib fracture and for an aged patient, it happens at a high frequency.Patient expired the following day.The cause of death was worsening of the primary disease (i.E., heart disease).The cause of cardio-pulmonary arrest (underling disease) was heart disease causing cardio-pulmonary arrest.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 5461842
• MDR Text Key: 39077365
• Report Number: 3010617000-2016-00113
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0701
• Device Catalogue Number: 8700-0701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 40