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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 11/03/2014

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2014, a male patient in his late 50s, weighing approximately 180lbs came into (b)(6) hospital after experiencing a cardiac arrest.The arrest occurred at the patient's place of residence.It is believed that the patient was down for approximately 40 minutes before (b)(6), the volunteer ems ambulance arrived on scene.It is unknown if bystander cpr was performed.(b)(6) ems, placed the patient onto a thumper device (not manufactured by zoll), which administered compressions on scene and throughout transport to the hospital for approximately 45 mins to 1 hour.The patient was transported to (b)(6) hospital er.At the emergency room, the ems crew took the patient off the thumper device.The er staff turned the platform on, prepped and placed the patient onto the autopulse.The patient was positioned, so that his armpits aligned with the autopulse using the yellow line as a guide.When the start/continue button was pressed, the platform displayed a user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) message.The er staff attempted to reset the platform, by assessing the patient's condition, resetting the lifeband and removing the battery.However, the ua would not clear.The autopulse never performed any compressions and use of the autopulse was discontinued.Er staff reverted to manual cpr for a few minutes, then switched back to the thumper device (exact length of time was not provided), until the er physician pronounced the patient.Patient was administered cardiac medications.Return of spontaneous circulation (rosc) was never achieved.Patient expired on the same day.Customer could not provide the cause of death and could not provide any patient medical history.Criteria for pronouncement is unknown.It is unknown if an autopsy was performed or is available.Customer also indicated that the relationship between use of the autopulse and the patient's death, is unrelated as efforts to resuscitate the patient, proved to be futile as patient was in an asystolic state.No further information was provided.

Manufacturer Narrative

Customer also indicated that later in the afternoon, on the same day, the autopulse platform was used on a mannequin and the same issue of the platform presenting with a user advisory (ua) 07 occurred.Product in complaint was returned to zoll on 11/10/2014 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned for evaluation.Visual inspection was performed and the top cover was cracked at the top right hand corner.The reported user advisory 7 (discrepancy between load 1 and load 2 too large) was observed during functional evaluation.No further testing could be performed as a result of the ua 7.Load cell characterization was performed and load cell module 2 was found to be over-reporting and causing the ua 7.Load cell module 2 was replaced in order to continue with the functional evaluation.A run in test with the (b)(4) lrtf (large resuscitation test fixture) and test batteries was performed for several hours with no faults or errors occurring.All parameters for the autopulse platform met manufactures specifications.A review of the archive shows multiple ua 7 codes being exhibited on the reported event date of (b)(6) 2014.Based on the investigation, the part(s) identified for replacement were the top cover and load cell module 2.In summary, the reported complaint was confirmed during review of the archive as well as functional testing and attributed to load cell module 2 not functioning properly.Following service, including replacement of the load cell, the device passed all testing criteria.

• 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: 4282247
• MDR Text Key: 5227592
• Report Number: 3010617000-2014-00623
• 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: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2008
• 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 Weight: 82