MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® NIMH BATTERY

Model Number 8700-0702-01

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2014

Event Type  malfunction  

Event Description

Complainant alleged that while medics were transporting a (b)(6) cardiac arrest patient, the autopulse® nimh battery ran in the autopulse platform for a couple of minutes and then stopped.The medics exchanged the battery with a backup and this battery ran until the patient was delivered to the hospital.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

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.

Manufacturer Narrative

The (b)(4) battery s/n (b)(4) associated with this complaint was returned to the manufacturer for investigation.The battery 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 335.0w.The battery was then fully charged and test cycled, then re-tested with the battery tester, where the results indicated that the battery was still below the minimum power output watts of 1300w with a reading of 759.8w.An investigation conducted using the batteries serial number, found that the battery was within its expected life span of 2-4 years with a manufacture date of 05/2011, and found the proper amount of test cycles (43 +/- 1 expected, 28 performed) had not been performed.The expected service life of the autopulse battery is 100 charge cycles or 2 to 4 years depending on battery maintenance and usage patterns.

• Brand Name: AUTOPULSE® NIMH BATTERY
• Type of Device: NIMH BATTERY
• 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: 4288189
• MDR Text Key: 5056480
• Report Number: 3010617000-2014-00633
• 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: 11/10/2014

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: 8700-0702-01
• Device Catalogue Number: 8700-0702-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 12/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2011
• 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
• Patient Age: 56 YR