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

Model Number	8700-0752
Medical Device Problem Codes	Low Battery (2584); Battery Problem (2885)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was reproduced during functional testing and confirmed through archive data review of the autopulse lithium ion battery (sn (b)(4)).The battery was received with no physical damage.The battery was received with four green 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 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 prior to the event date, multiple incidence of the battery being left in the autopulse for an extended amount of time and the battery enetring a discharged state, and events wherein the battery was prematurely removed from the autopulse multi chemistry charger without completing the testing cycle.It was indicated that on (b)(6) 2018, the battery was reconditioned in the mcc and was able to successfully charge.Following this, another mcc charging cancellation was recorded.The archive data recorded multiple field effect transistor (fet) test and other battery errors during this event.These battery errors are due to a damaged transistor likely related to electro static discharge.
Event or Problem Description
During routine testing, a fully charged (four green led) autopulse li-ion battery (sn (b)(4)) was inserted into the autopulse platform and displayed a "replace battery" message.The user further tested the battery in the autopulse multi-chemistry charger (mcc), and battery charging was unsuccessful.The platform was tested and operated as expected with no issue.No patient involvement was reported.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Common Device Name: LI-ION BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7382959
• Report Number: 3010617000-2018-00318
• Device Sequence Number: 13761294
• Product Code: DRM
• UDI-Device Identifier: 00849111001847
• UDI-Public: 00849111001847
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8700-0752
• Device Catalogue Number: 8700-0752-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1