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

Model Number 8700-0752-01

Device Problems Failure to Charge (1085); Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 05/15/2015

Event Type  malfunction  

Event Description

It was reported that when autopulse li-ion battery with serial number (sn) (b)(4) was tested, it either did not charge or it provided an indication that it was fully charged.When the same battery was installed into the autopulse platform, the lcd display exhibited a "replace battery" message.There was no report of any patient involvement.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

Autopulse li-ion battery (s/n (b)(4)) was returned to zoll (b)(4) for evaluation.Visual inspection was performed and no damage was observed to the battery case and or the connector terminals.Upon receipt, the battery charge status indicator showed 4 green leds.After charging the battery, 4 green leds were still illuminated.The battery was then inserted into the autopulse platform and the platform was run for 47 minutes using a standard mannequin and no problems were observed.After the run, the battery was then re-charged and re-inserted into the platform, and all 4 battery charge status indicators were illuminated.The reported complaint was not confirmed.Therefore, a root cause could not be determined.The battery passed all testing.

• 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: 4860424
• MDR Text Key: 5850064
• Report Number: 3010617000-2015-00346
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2014
• 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