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

Model Number 8700-0752-01

Device Problems Low Battery (2584); Battery Problem (2885)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 09/20/2015

Event Type  malfunction  

Manufacturer Narrative

The customer also reported that after the battery was fully charged, it self discharged to 50 % in 2 days without being used.Product in complaint was returned to zoll on (b)(6) 2015 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Event Description

It was reported during patient use that the autopulse li-ion battery stopped working.No adverse patient sequelae was reported.No additional details were provided.

Manufacturer Narrative

The li-ion battery (s/n (b)(4)) was returned to zoll for evaluation.Visual inspection was performed and no damages were observed.The reported complaint was not confirmed.Review of the archive revealed multiple communication errors occurred due to low battery voltage.Unable to replicate the reported event during investigation.No issues were reported during 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: 5189774
• MDR Text Key: 29920906
• Report Number: 3010617000-2015-00597
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• 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: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• 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
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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