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

Model Number 8700-0752

Device Problems Low Battery (2584); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event was reproduced during functional testing and confirmed through archive data review of the autopulse lithium ion battery ((b)(4)).The battery was received with no physical damage with two amber leds illuminated on the battery status indicator.The battery was functionally tested by inserting into a good known reference autopulse multi chemistry charger (mcc) and the mcc illuminated a red battery charger led indicating that the mcc was unable to charge the battery.Review of the retrieved archive data revealed that the battery was left inside the autopulse platform for an extended period of time staring on (b)(6) 2017 for 12.2 days without being recharged in the mcc.The battery entered into preserved mode and displayed multiple battery errors related to an electro static discharge (esd).Following this the battery was reconditioned once properly charged into an mcc and became operational.Starting on (b)(6) 2017, the battery sat idle and uncharged for 74.3 days until being reconditioned in the mcc.On (b)(6) 2018, the battery was inserted in an autopulse platform and recorded multiple elevated temperature readings on the battery thermistor and multiple battery errors.The autopulse power system user guide states that "after every use, at the beginning of a shift, or at least once every 24 hours, the battery in the autopulse should be replaced with a fully charged battery." a fully charged autopulse lithium ion battery left in a zoll autopulse platform for an extended period of time will eventually discharge below its minimum operating voltage.A fully discharged battery will not display any led status lights and will not be able to charge in the mcc.

Event Description

During routine testing, a fully charged autopulse li-ion battery ((b)(4)) (with four green leds illuminated on the battery status indicator) was inserted in an autopulse platform.The platform was unable to power on.Following this the platform was tested using another battery and powered on, operating as expected.The battery ((b)(4)) was inserted in an autopulse multi chemistry charger (mcc) and was unable to successfully charge.The mcc displayed a red charger led.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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7445576
• MDR Text Key: 106303575
• Report Number: 3010617000-2018-00402
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• 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: 03/28/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2017
• 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