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

Model Number 8700-0701-01

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 02/04/2014

Event Type  malfunction  

Event Description

Complainant initially reported that during a shift check, the lifeband was pulled out of the box and the customer noticed that the black belt guard clip that locks onto the side of the platform was broken.Manufacturer obtained further information on (b)(4) 2014 from the customer, who indicated that the broken lifeband was actually used on a patient.The details are reflected below: customer reported that they received an initial call for a (b)(6) year old male patient, weighing (b)(6) who was experiencing a cardiac arrest, later determined to be stemi (st segment elevation myocardial infarction).It is unknown how long the patient was down.Bystander cpr was performed for approximately 5-6 minutes prior to ems arrival.Ems arrived and manual cpr was performed for 1 minute while the autopulse was being placed under the patient.Customer pressed the start/continue button to allow the lifeband to analyze the patient's size.The lifeband retracted successfully to engage the first compression.The lifeband then stopped and released the tension prior to completion of the first compression.The user made three attempts to pull the band up to a fully extended position and then pressed the restart button, however the issue would not resolve.Patient presented ventricular fibrillation symptoms, therefore a shock was delivered to the heart.Use of the autopulse was discontinued after 4 minutes following arrival of ems.Crew reverted to manual cpr for the remainder of the call, while continuing bvm (bag-valve-mask) ventilation.Patient also received endotracheal intubation as well as ivs and several rounds of epinephrine and lidocaine.After patient was given a second shock to the heart, rosc (return of spontaneous circulation) was almost achieved.Ems crew continued with ventilation and transport.Patient was later sedated for transport to the regional pci (percutaneous coronary intervention) unit.After therapeutic hypothermia and catheter lab procedures including some time on a balloon pump were performed, the patient was released home.No further details were provided.

Manufacturer Narrative

Customer reported that after the end of the call, the autopulse and lifeband were evaluated to determine the cause of the issue.It was discovered that the black belt guard clip on the autopulse lifeband had broken which caused the lifeband to bind and pull the outer sheath of the lifeband into the broken clip.Zoll circulation has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

• Brand Name: AUTOPULSE® LIFEBAND
• Type of Device: CHEST COMPRESSION ASSEMBLY
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192957
• MDR Report Key: 3654392
• MDR Text Key: 4347819
• Report Number: 3003793491-2014-00116
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/04/2014

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: 8700-0701-01
• Device Catalogue Number: 8700-0701-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2014
• Initial Date FDA Received: 03/03/2014
• 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
• Treatment: MANUAL CPR
• Patient Age: 51 YR
• Patient Weight: 100