MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE® LI-ION BATTERY

Model Number 8700-0752-01

Device Problems Device Alarm System (1012); Loss of Power (1475)

Patient Problem Death (1802)

Event Date 03/26/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, customer responded to a call regarding a (b)(6), unresponsive male patient with possible cardiac arrest.The arrest was unwitnessed.Patient went into the bathroom.His family heard a noise and went to find him not breathing on the bathroom floor.He was down for about 5-10 minutes prior to customer's arrival.The first crew member on scene performed manual cpr for about a minute.The rest of the crew arrived shortly after and the autopulse platform was prepared for deployment in the bedroom.Patient was moved from the bathroom to the bedroom floor and placed on the platform.The autopulse was deployed without any issues.The platform performed compressions for about 2 minutes and then stopped.The lcd screen went blank.No error messages were observed.Crew lifted the platform and thought that the on/off button was bumped so they set it back down and restarted the platform.Platform gave a "pull up on the lifeband" message and crew pulled up the lifeband to begin compressions.The 5-6 compressions were made before the platform stopped again.Manual cpr was then initiated (exact length of time not provided) and patient was transferred to the cot (gurney).Customer placed the spare li-ion battery into the platform, which ran for 2 minutes and then stopped.Screen went blank again.Customer pressed the status check button on the first battery and no led's were lit.The spare battery was also checked and no led's were lit as well.Customer reverted to manual cpr for 6-7 minutes while the patient was being transported to the ambulance.Customer stated that head immobilizers and shoulder restraints were used.An ekg monitor indicated that the patient was asystolic with a short bout of pea.Patient was administered several rounds of epinephrine and atropine.The hospital was 16 miles from the scene of event with a transport time of 18-20 minutes.The spare battery was put back into the platform but it stopped working 3-4 minutes into transport.Customer reverted to manual cpr for the remainder of transport which was about 17 minutes.Patient care was transferred at the hospital and resuscitation efforts were continued until terminated by the physician.Return of spontaneous circulation (rosc) was never achieved.Patient had a history of drug abuse, back pain and previous cardiac arrest.An autopsy report is not available at this time.The lieutenant who was on the call does not know if the outcome would be any different and does not believe that the autopulse stoppage was the entire reason for the patient's death.The fire chief does not attribute the patient's death to the autopulse stoppage and indicated that heroin overdose may have been a contributing factor.

Manufacturer Narrative

Customer was using li-ion batteries.The batteries charged up ok when they were initially received.The green led was lit on both batteries.Customer indicated that the batteries are rotated every morning.After the reported event, customer came back to their station.They placed a battery from the charger into the platform and it appeared to be operating normally.The product in complaint was returned to zoll on (b)(6) 2014 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.Please see the following related mfr.Reports: #3003793491-2014-00198 for autopulse resuscitation system model 100 with sn: (b)(4); #3003793491-2014-00200 for autopulse li-ion battery with sn: (b)(4).

Manufacturer Narrative

Investigation results for the returned battery as follows: visual inspection of the returned battery identified excessive physical damage to its case sustained during use in the field.The battery archive analysis indicated that the battery had t3 thermocouple chip damage which had been caused by mechanical impact damage.Based on the evaluation findings, the anomalies noted with the battery are considered unrelated to the reported event of the platform experiencing un-commanded shutdowns while used with this battery.Evaluation of the autopulse (sn: (b)(4)) archive shows that li-ion battery (s/n (b)(4)) was fully charged when being used with the platform and was used on an object which was hard to compress.Although, the customer's reported complaint of experiencing un-commanded shut offs could not be reproduced during functional testing, it was confirmed during review of the autopulse platform archive.Based on the reported information, the patient's ekg showed that the patient was asystolic with pea.Survival rates in a cardiac arrest patient with asystole are extremely low.The patient never achieved rosc even with manual compressions.In addition, the customer states that because the patient had a history of drug abuse and previous cardiac arrests, they did not attribute patient's death to the autopulse.The fire chief also confirmed that the cause of death was due to a heroin overdose.Please see the following related mfr.Reports: #3003793491-2014-00198 for autopulse® resuscitation system model 100 with sn: (b)(4).#3003793491-2014-00200 for autopulse® li-ion battery with sn: (b)(4).

Event Description

Additional information obtained from the customer: the fire chief confirmed that the cause of death of the patient was a heroin overdose.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY
• 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: 3762525
• MDR Text Key: 18813951
• Report Number: 3003793491-2014-00199
• 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: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0752-01
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2012
• 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: 39 YR
• Patient Weight: 150