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

Model Number 8700-0752

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During routine testing, the autopulse platform displayed "replace battery" message.Per the report, the autopulse li-ion battery ((b)(4)) was successfully charged in the autopulse multi-chemistry charger (mcc) prior to insertion in the platform.There was no patient involvement.

• 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 7668423
• MDR Text Key: 113394946
• Report Number: 3010617000-2018-00703
• 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: company representative,health
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 07/06/2018

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: 8700-0752
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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