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

Model Number 8700-0752

Device Problems Battery Problem (2885); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2017

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse li-ion battery in complaint for investigation.A supplemental report will be filed when the investigation has been completed.

Event Description

It was reported that the autopulse lithium ion battery (sn (b)(4)) was placed in the autopulse platform for patient use.Autopulse platform powered off after performing cpr for an unspecified amount of time.After exchanging to another battery (sn unknown) the platform performed approximately 10 minutes of compression until a recurrence of the platform powering off was again observed.Third battery was used and platform was performing compressions as expected.No patient harm or consequences reported on this event.Additionally, the customer tested first battery on a platform and it showed a fully charge status.No additional information was provided.This report is for second autopulse li-ion battery sn unknown.For issue with the first battery (sn (b)(4)) see mfr 3010617000-2018-00416.

• 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: 7394517
• MDR Text Key: 104540311
• Report Number: 3010617000-2018-00417
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• 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
• Date Manufacturer Received: 03/04/2018
• 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