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 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

The autopulse li-ion battery in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

The autopulse platform (sn (b)(4)) was inserted a fully charged autopulse li-ion battery and operated for approximately 15 to 20 minutes before powering off by itself.The issue occurred during routine testing, no patient was involved.This references the report of the battery not holding charge.The report of the platform powering off by itself is referenced under mfr 3010617000-2017-01087.

• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7149957
• MDR Text Key: 95953793
• Report Number: 3010617000-2017-01088
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/27/2017

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/27/2017
• 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