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

Model Number	MODEL 100
Medical Device Problem Codes	Low Battery (2584); Battery Problem (2885)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two li-ion batteries (s/n (b)(4)) were returned to zoll (b)(4) for evaluation.Both li-ion batteries showed green leds before and after charging indicating that the batteries performed as intended.See mfr report # 3010617000-2016-00350 for the 1st battery.
Event or Problem Description
The customer reported that during daily shift check, when they placed a known fully charged battery into the autopulse, the platform displayed "replace battery" message upon power-up.The customer did not see any user advisory codes.They only saw "empty battery" icon on the display.The customer knew these were fully charged because their mcc indicated green led (fully charged) on the display.There was no patient involvement 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: 5668875
• Report Number: 3010617000-2016-00341
• Device Sequence Number: 13494306
• Product Code: DRM
• UDI-Device Identifier: 00849111065054
• UDI-Public: 00849111065054
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2016

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: MODEL 100
• Device Catalogue Number: 8700-0752-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2016
• Initial Report FDA Received Date: 05/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1