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

Model Number 8700-0752

Device Problems Failure to Power Up (1476); Charging Problem (2892)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was confirmed during functional testing of the returned autopulse lithium-ion battery.The battery failed to charge in a known good multi-chemistry charger.Dents on the battery case were observed, and four green lights were lit on incoming inspection.From the battery archive review, on june 4, 2018, to the end of the archive on july 11, 2018, battery recorded multiple temperature mismatch error messages during each customer's autopulse used/insertions and charged attempts.The battery was last charged successfully on (b)(6) 2018, and was last inserted/used in the autopulse by the customer the same day.The cause for this battery failure, based on the review of the battery, is due to a mechanical impact resulting in a damage of one of the battery temperature sensors.As a result, the battery could not be charged and failed in the autopulse platform.

Event Description

The autopulse li-ion battery ((b)(4)) failed to power up the autopulse platform during patient use.Following this, manual cpr was immediately performed while the battery was exchanged.A new battery was replaced and the platform functioned without any issues.No known impact or consequence to the patient.No other information was provided.The customer stated that the battery status was checked with 4 green leds when pressing the battery status button.Following this, the customer inserted the battery in an autopulse multi-chemistry charger and was unable to successfully charge.

• 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: 7701426
• MDR Text Key: 114426767
• Report Number: 3010617000-2018-00736
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2017
• 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