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

Model Number 8700-0752-01

Device Problems Loss of Power (1475); Charging Problem (2892); Failure of Device to Self-Test (2937)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2015

Event Type  malfunction  

Event Description

It was reported that the autopulse platform ran using autopulse li-ion battery with serial number (sn) (b)(4) for only 39 seconds and then powered off.Customer stated that the battery was fully charged and had a good remaining capacity when it was placed into the platform.Customer took the battery out and tested it in another charger, which showed that the battery did not pass testing.However, the same battery was then placed into the original charger, which showed that the battery charged up ok and passed testing.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

Zoll has not yet received the autopulse battery in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The autopulse li-ion battery (s/n (b)(4)) was returned to the manufacturer for evaluation.Visual inspection of the returned battery was performed and no physical damages were observed.The customer's reported complaint of the battery being unable to charge was confirmed.A review of the battery's archive was unable to be performed as the archive was corrupted and could not be retrieved.Therefore a root cause could not be determined.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION 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: 4909883
• MDR Text Key: 6834465
• Report Number: 3010617000-2015-00396
• 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,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• 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: 07/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2015
• 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