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

Model Number	8700-0752-08
Medical Device Problem Codes	Low Battery (2584); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported issue of the battery no longer hold a charge was confirmed during the functional testing and in archive review data.The battery was tested in a good known multi chemistry charger and the battery failed to charge.The root cause of the reported problem could not be determined however, a likely root cause for the battery failure based on the archive information can be due to electro static discharge (esd).The esd causes the battery gas-gauge latch-up, which causes a malfunction on the battery smbus (i2c) interface to communicate with the battery microprocessor.Visual inspection noted no damage upon receipt.There were no leds of any type were lit on incoming inspection.Archive showed that the battery generated multiple series of back side bus i2c errors, gas gauge errors from start to the end of the archive, over writing the write and seal data and dates.Functional testing was performed and the battery failed charging in a known good multi chemistry charger with red light flashing after the charged attempt.Battery thus failed the functional testing.
Event or Problem Description
As reported, during shift check, the li-ion battery (b)(4) was indicating four green leds when the status button was pressed.When the battery was inserted into the autopulse platform, it was displaying an error message "replace / recharge battery".After the battery was inserted into the multi-chemistry charger (mcc), it was indicating fail (red) led.Battery status however, still indicating four green leds.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: 7069663
• Report Number: 3010617000-2017-01062
• Device Sequence Number: 1472031
• Product Code: DRM
• UDI-Device Identifier: 00849111001854
• UDI-Public: 00849111001854
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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: 8700-0752-08
• Device Catalogue Number: 8700-0752-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1