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

Model Number MODEL 100

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse li-ion battery (sn (b)(4)) failed to power up the autopulse platform" was confirmed during the functional testing and the archive data review.The root cause for the reported complaint was due to the damaged onboard temperature sensors as a result of mechanical impact, likely caused by user mishandling.Upon visual inspection, no physical damage was observed and the battery status led's showed four green lights.The autopulse li-ion battery failed charging in the good known autopulse multi-chemistry battery charger (mcc), however, the battery status led's showed four green lights after charging attempt.The battery was tested in a good known autopulse platform and the platform indicated 4 battery bars.But the platform failed to power up when the power button was pressed and the power button was pressed several times for the device to power on again.The battery archive data showed that the battery recorded multiple temperature mismatch error messages on thermistor # 0 and # 2 during each customer's charging attempts.The most common cause for this error was due to mechanical impact which caused damage to one or more of the on-board temperature sensors.The damaged temperature sensor reported a temperature that was off the chart.

Event Description

During patient use, the autopulse li-ion battery (sn (b)(4)) failed to power up the autopulse platform (sn (b)(4)).The crew immediately replaced the battery to continue the compressions on the patient.Rosc (return of spontaneous circulation) was not achieved and the patient was pronounced dead.Per user, the battery (sn (b(4)) was charged successfully prior to the patient use.After patient use, the crew placed the battery in the autopulse multi-chemistry battery charger (mcc) and the charger disabled the battery.The status led on the charger showed red light.No device malfunction was reported on the autopulse platform.Per user, the patient's outcome was not related to the autopulse.Please see the following related mfr report: mfr # 3010617000-2019-01105 for the autopulse platform.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY, RECHARGEABLE
• 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: 9453963
• MDR Text Key: 178665770
• Report Number: 3010617000-2019-01104
• Device Sequence Number: 1
• Product Code: MOQ
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: D163369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2019
• 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