MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE® NIMH BATTERY

Model Number 8700-0702

Device Problem Loss of Power (1475)

Patient Problem Death (1802)

Event Date 12/18/2013

Event Type  Death  

Event Description

Customer received a call regarding an unresponsive, (b)(6)-year-old male patient.The patient was found at his place of residence at 10:35 pm.He was down for an unknown length of time but it is believed that it was for a short period.Bystander cpr was performed at 10:36 pm for approximately 3 minutes before ems crew arrived on scene.The autopulse platform was deployed with no issues.Two autopulse nimh batteries were used during this case.The first nimh battery performed compressions for about two minutes and then stopped compressions.The second nimh battery performed compressions for about three minutes and then stopped compressions.Use of the autopulse was discontinued.Crew reverted to manual cpr for the remainder of the call which was approximately 15-20 minutes.Patient was transported to the county hospital.Patient did not survive and did not regain return of spontaneous circulation (rosc).No further information was provided.

Manufacturer Narrative

Customer reported that the battery is one and half years old and has 7 deep cycles on it.Zoll 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.Please see the following related mfr.Report: 1.#3003793491-2014-00010 for autopulse nimh battery with sn: unknown.

Manufacturer Narrative

Nimh battery s/n (b)(4) associated with this complaint was not returned to zoll for investigation.An investigation conducted using the battery's serial number, found that the battery was within its expected life span of 2-4 years.However, it was reported by the customer that this battery only had 7 test cycles performed at the time of the reported complaint.As this battery was manufactured in may of 2012, the expected amount of test cycles would be 19 +/- 1.As proper battery maintenance was not performed (charged/test cycled) as instructed per the autopulse user guide, the battery's lifespan was effected.The customer's reported complaint of experiencing a low run time was confirmed through review of the archive records for autopulse platform s/n (b)(4), which was the platform in which the battery was used during the patient event.Nimh battery s/n (b)(4) was placed into the platform and was used for 2 minutes and 43 seconds, performing 82 compression until a low battery warning and user advisory (ua) 44 (battery voltage too low during compression (replace battery)) messages were displayed.The platform was turned off and back on without the battery being changed, which caused a ua13 (battery fault detected) to be displayed (please note that once a ua44 is displayed, if the battery is not changed, a ua13 will occur to prevent insufficient compressions from being performed).The platform was again turned off and back on without the battery being changed.As a result, the platform once again displayed a ua13.Additional review of the platform's archive data was conducted to ascertain whether this battery was properly maintained prior to this event.The first time that this battery was used in this platform was (b)(6) 2012, at which time the battery had undergone 2 test cycles.This battery was also used in the platform on (b)(6) 2012, (b)(6) 2012, (b)(6) 2013, and (b)(6) 2013.On all of these dates, the archive shows that battery had not undergone any test cycles, still only having 2 performed.The battery next appears in the archive on (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, and (b)(6) 2013, with 4 test cycles having been performed.On (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, the battery was recorded in the archive with 5 test cycles.On (b)(6) 2013, and (b)(6) 2013 (the date of the reported event), 6 test cycles were recorded in the archive data.The lack of regular test cycles indicates that this battery was not properly maintained.As previously stated, not maintaining the battery per the autopulse user guide will effect the battery's lifespan.

• Brand Name: AUTOPULSE® NIMH BATTERY
• Type of Device: NIMH 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: 3563235
• MDR Text Key: 4210681
• Report Number: 3003793491-2014-00009
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0702
• Device Catalogue Number: 8700-0702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2012
• 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 Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 109