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

Model Number 8700-0702-03

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 10/21/2013

Event Type  malfunction  

Event Description

Complainant indicated that a call was dispatched on (b)(6) 2013, concerning a (b)(6) cardiac male patient weighing (b)(6) kg.It is unknown if this was a witnessed arrest.The length of time that patient was down or if bystander cpr was performed prior to deployment of the autopulse is unknown.Customer reported that the autopulse platform was deployed without any issues.Mechanical compressions were performed.During transport of the patient to the hospital, complainant alleged that the device lost power three times, however, on the fourth attempt within a few minutes the device functioned properly.Manual cpr was performed when the autopulse stopped working (exact length of time is unknown).No error codes were observed.The patient did not achieve rosc (return of spontaneous circulation).It is unknown if manual cpr was performed at the hospital.The patient was pronounced dead at the hospital by physician.Customer does not attribute the patient's death to the autopulse stoppage.The cause of death was due to deterioration of myocardial infarction.No further information was provided.

Manufacturer Narrative

Autopulse platform s/n (b)(4) and 2 nimh batteries (s/n's (b)(4)) were all returned to zoll for investigation.This investigation will capture the results of nimh battery s/n (b)(4).Upon return to zoll, battery s/n (b)(4) was placed in the battery tester, and the results indicated that the battery was below the minimum power output watts of 1300w with a reading of 822.7 w.The battery was then fully charged and test cycled, then re-tested with the battery tester, where the results indicated that the battery was below the minimum power output watts of 1300w with a reading of 1143.2w.Test results indicated that the battery was above the maximum impede of 230 ohms with a reading of 299.03 ohms.Upon completion of a charge cycle, this battery was used on autopulse platform s/n (b)(4), and performed run_in testing successfully for 35 minutes with a 95% test fixture.Because the battery was used directly from the charger, it performed as intended, had this battery been allowed to sit for a significant length of time before performing the run_in testing, the testing would most likely have only performed for a few minutes because of the afore mentioned high internal impedance of the battery.A delay between charging and actual use reflects how the customer may use the battery.An investigation conducted using the battery's serial number, found that the battery was within its expected life span of 2-4 years.The expected service life of the autopulse battery is 100 charge cycles or 2 to 4 years depending on battery maintenance and usage patterns.Battery s/n (b)(4) shows an adequate number of test cycles.However, based on zoll's experience with a large amount of battery customers, it is very likely that the battery was not properly maintained and upon becoming aware of the importance of battery maintenance, the customer performed more frequent test cycles.History has shown that not test cycling the battery at least once every 30 days leaves irreversible damage that is not corrected with more frequent test cycles.Please see the following related mfr reports: # 3003793491-2014-00078 for autopulse resuscitation system with sn (b)(4); # 3003793491-2014-00079 for autopulse nimh battery with sn (b)(4).

• Brand Name: AUTOPULSE® NIMH BATTERY
• Type of Device: AUTOPULSE® 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: 3623528
• MDR Text Key: 4209862
• Report Number: 3003793491-2014-00080
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/09/2013

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: 8700-0702-03
• Device Catalogue Number: 8700-0702-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2013
• Initial Date FDA Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 60 YR
• Patient Weight: 80