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

Model Number 8700-0752-01

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.

Event Description

During shift check, customer reported that the autopulse li-ion battery (b)(4) did not power-on the autopulse platform.The battery was charged on the same day before the incident and the battery status showed four green leds illuminated prior to placing into the platform.Other autopulse li-ion batteries were able to power-on the platform.No patient involvement.

Manufacturer Narrative

The reported complaint of autopulse li-ion battery (serial # (b)(4) did not power-on the autopulse platform was confirmed during functional testing and during archive review.The returned battery failed charging in a known good multi chemistry charger and failed to power up the autopulse platform.Dents on the returned battery case was observed during visual inspection.Also, three amber lights flashed when the status button was pressed.Three amber lights flashing indicates that the battery is not fully charged.During returned battery's archive review, battery recorded a preserved mode with possible one or more battery cells were discharged below 2.0 volts followed by a battery reset and clock glitch with another preserved error messages.Thus, confirming the reported complaint.Also in the archive, battery was last charged successfully on (b)(6) 2018 and was last used/inserted in the autopulse on (b)(6) 2018.Based on the archive review, the investigation findings revealed that the probable cause of the reported issue was due to a mechanical impact as a result of a damaged/broken components on the battery management board.Returned battery has not reached its service life of three years from its date of manufacture; however, since the returned battery is non-operable, it will be scrapped.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8293500
• MDR Text Key: 134626697
• Report Number: 3010617000-2019-00058
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0752-01
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Date Manufacturer Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1