MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE LI-ION BATTERY; COMPRESSOR, CARDIAC, EXTERNAL

Model Number 8700-0752-01

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse li-ion battery for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

As reported, during the training, a fully charged autopulse li-ion battery (sn (b)(4)) was removed from the multi-chemistry charger (mcc) and placed into the autopulse platform.However, the battery failed to power up the platform.The battery was placed back for charging and was disabled by the charger.No patient involvement.

Manufacturer Narrative

The battery failed to charge in a known good multi-chemistry charger.The battery was tested in a known good autopulse platform and failed to power up, confirming the customer complaint.No physical damage was observed and three amber lights were lit on incoming inspection.The battery archive was downloaded and reviewed.The cause for this battery failure, based on the review of the battery, is due to battery mismanagement and charging practice by the customer.The battery was left multiple times in the autopulse platform for an extended period of time and let it deplete below operating voltage.As a result of these errors, the battery failed to charge in the multi-chemistry charger and failed to power up the autopulse platform.The autopulse power system user guide states that "after every use, at the beginning of a shift, or at least once every 24 hours, the battery in the autopulse should be replaced with a fully charged battery." a fully charged autopulse lithium-ion battery left in a zoll autopulse platform for an extended period of time will eventually discharge below its minimum operating voltage.A fully discharged battery will not be able to charge in the mcc.

• Brand Name: AUTOPULSE LI-ION BATTERY
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 8676924
• MDR Text Key: 147308669
• Report Number: 3010617000-2019-00465
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• 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: 07/11/2019

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
• 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: 06/19/2019
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 06/06/2019
• Supplement Dates Manufacturer Received: 06/28/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1