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

Model Number 8700-0752

Device Problems Low Battery (2584); Charging Problem (2892)

Patient Problem No Patient Involvement (2645)

Event Date 10/15/2015

Event Type  malfunction  

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.

Event Description

Customer reported that during a routing shift check the li-ion battery showed that it was fully charged, however it would only give about 5 minutes of run time.No patient involvement was reported.No additional information provided.

Manufacturer Narrative

The li-ion battery (s/n (b)(4)) was returned to zoll (b)(4) for eval.Visual inspection was performed and no physical damage was observed to the battery.Functional testing of the battery was performed and the battery passed all testing criteria.The reported complaint of the this li-ion battery will only give about 5 minutes run time was not confirmed.

Manufacturer Narrative

Supplemental for patient identifier (b)(6), was submitted electronically on march 21, 2016; however, labeled under an incorrect manufacturer report number (3003793491-2015-00058).The correct mfr report number for ccr #21089 is 3010617000-2015-00586.Information from the previous supplemental has been transferred to this report.Investigation: the li-ion battery (b)(4) was returned to zoll (b)(4) for evaluation.Visual inspection was performed and no physical damage was observed to the battery.Functional testing of the battery was performed and the battery passed all testing criteria.The reported complaint of this li-ion battery will only give about 5 minutes run time was not confirmed.

• 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: 5219007
• MDR Text Key: 30984061
• Report Number: 3010617000-2015-00586
• 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,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8700-0752
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2016
• 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