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

Model Number	8700-0752
Medical Device Problem Codes	Low Battery (2584); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse li -ion battery in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed if the product is returned and investigation has been completed.
Event or Problem Description
As reported during device check, the li-ion battery (sn: (b)(4)) was indicating four green leds when the status button was pressed; however, when the battery was inserted into the autopulse platform, it was displaying an error message "replace battery/charge".When the battery was inserted into the multi-chemistry charger (mcc), it was indicating fail (red) led.The battery was last charged successfully on (b)(6) 2017.The customer follows three battery rotation as recommended by zoll.The platform used is working as intended for use with other li-ion batteries.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: 7008408
• Report Number: 3010617000-2017-00885
• Device Sequence Number: 19150614
• Product Code: DRM
• UDI-Device Identifier: 00849111001847
• UDI-Public: 00849111001847
• Combination Product (Y/N): N
• Initial Reporter Country: WZ
• 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): 11/07/2017

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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1