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

Model Number 8700-0752

Device Problems Device Issue (2379); Battery Problem (2885)

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

Event Date 12/26/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the autopulse lithium ion battery (sn (b)(4)) found no functional issue; however, review of the archive data revealed an event on (b)(6) 2017 consistent with the customer reported event that occurred on (b)(6) 2017, thus confirming the reported event.The autopulse battery is a reusable device and was manufactured on mar 2015 it is approaching its expected service life of 3 years.The battery was received with no physical damage and three amber led illuminated on the battery status indicator.The battery was functionally tested by inserting into a good known reference autopulse multi chemistry charger (mcc) and was able to successfully charge the battery with four green leds illuminated on the battery status indicator.Review of the retrieved archive data indicates that the battery was last charged successfully on (b)(6) 2017 and last inserted in the autopulse platform on (b)(6) 2017 without error.On (b)(6) 2017, the battery was inserted in an autopulse platform and displayed a battery error.Additionally, the reported event was also consistent with the events in the archive data retrieved from the returned autopulse platform (sn (b)(4)).The issue is likely attributed to the stiffness of the patient's chest, and/or the length of time the battery was used performing continuous compression causing the battery's state of charge to diminish at a faster rate.The investigation result for the platform is referenced under mfr 301067000-2018-00067.

Event Description

The autopulse platform (sn (b)(4)) inserted with the autopulse li-ion battery (sn (b)(4)), was used during patient response while in transport.At an unspecified time during operation, the platform powered off by itself.Following this, manual cpr was immediately performed.After exchanging to another battery (sn (b)(4)) the platform performed approximately 10 minutes of compression until a recurrence of the platform powering off was again observed.The patient received manual cpr until the patient was handed over to the hospital.No known impact or patient consequence was reported.It was further reported that the user checked the batteries and it was indicated that the batteries had ample charge with three leds illuminated on the battery status indicator.This references the report low battery run time on battery (sn (b)(4)).Reference mfr 3010617000-2018-00067 for the report of the autopulse platform powering off by itself and mfr 3010617000-2018-00069 for the report of low battery run time on battery (sn (b)(4)).

• 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: 7216215
• MDR Text Key: 98296846
• Report Number: 3010617000-2018-00069
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• 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: 01/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2015
• 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