MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE RESUSCITATION SYSTEM MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

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

Patient Problems Death (1802); Ventricular Fibrillation (2130)

Event Date 03/06/2015

Event Type  malfunction  

Event Description

It was reported that a (b)(6) year old female patient weighing approximately (b)(6), was found unconscious and unresponsive at her place of residence.The patient was last seen by her son approximately 3 hours prior to being found laying on the floor.The son dialed 911 and upon ems arrival the patient was found unresponsive on the floor in cardiac arrest.Bystander cpr was not performed prior to their arrival.Manual cpr was initiated immediately and performed for approximately 4 minutes prior to deployment of the autopulse.The medic stated that the patient was properly positioned on the platform and the lifeband was properly positioned at the armpit line without any issues.The autopulse failed to initiate any compressions.To ensure that there were no twists in the lifeband, the user checked both the patient and lifeband positions and pressed restart.The medic then tried to reposition the patient, however the autopulse continued to display a user advisory 7 (discrepancy between load 1 and load 2 too large) message.The medic pulled up the lifeband and pressed restart three times, however the issue would not resolve.Use of the autopulse was discontinued and manual cpr was resumed for an unknown length of time.The patient initially presented in v-fib, which later declined into asystole.The patient was extricated onto a backboard and transported to the local er.Rosc was never achieved and the patient was pronounced dead by the er physician.The cause of death is unknown, however customer does not attribute the patient's death to use of the autopulse.It is unknown if an autopsy was performed.No further information was provided.

Manufacturer Narrative

Product in complaint was returned to zoll on 03/20/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

Autopulse platform with serial number (sn) (b)(4) was returned to zoll for evaluation.Visual inspection of the returned platform was performed which found that the front cover was cracked.The physical damage found during visual inspection is not related to the customer's reported complaint of the autopulse displaying a user advisory 7 (discrepancy between load 1 and load 2 too large) message.A review of the platform's archive data was performed and found multiple user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) messages on (b)(6) 2015, rather than the reported event date of (b)(6) 2015.Per the autopulse maintenance guide (p/n 11653-001), ua 7 is an indication that the patient is out of position or the patient is not properly centered.The recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.The customer's reported complaint was not duplicated during functional testing.The platform passed a load cell characterization test, which confirmed that both load cells were functioning within specification.The load cell characterization test can confirm that the patient either wasn't placed correctly on the device or the patient possibly moved during compressions.After load cell characterization testing, the platform ran with a 95% patient test fixture (lrtf) for several hours with no issues observed.Based on the investigation, the part identified for replacement was the front cover.In summary, the customer's reported complaint that the platform displayed a user advisory 07 message was confirmed during review of the platform's archive data.There were no device deficiencies found during evaluation of the platform which could have caused or contributed to the reported event.The platform passed load cell characterization testing, which confirmed that both load cells were functioning within specification.The physical damage found during visual inspection is also unrelated to the customer's reported complaint.The platform is a reusable device and therefore, these types of physical damages can occur due to normal wear and tear and/or physical abuse.After replacement of the front cover, the platform passed all final functional testing criteria.Based on the information received from the customer, rosc was never achieved with manual compressions, which is standard of care.The customer did not attribute patient death to the autopulse device.Additionally, the customer indicated that the patient was asystole.Survival rates in a cardiac arrest patient with asystole are extremely low.It is reasonable to conclude that the patient death was due to progression of an underlying condition.

• Brand Name: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• 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: 4653443
• MDR Text Key: 15962813
• Report Number: 3010617000-2015-00190
• 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,Followup
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MANUAL CPR
• Patient Age: 91 YR
• Patient Weight: 50