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

Model Number MODEL 100

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse li-ion battery (sn (b)(4)) for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.

Event Description

During training, the autopulse li-ion battery (sn (b)(4)) status led showed that the battery was completely charged, however, when placed in the autopulse platform, the platform powered off.The user checked the autopulse platform with other working battery and the battery worked as intended.No patient involvement.

Manufacturer Narrative

The reported complaint of "the autopulse li-ion battery (sn (b)(4) status led showed that the battery was completely charged, however, when placed in the autopulse platform, the platform powered off" was confirmed during the functional testing and the archive data review.The possible root cause for the reported complaint was due to battery mismanagement and charging practices by the customer.Upon visual inspection, no physical damage was observed and four green led lights were lit on incoming inspection.The battery failed charging in a known good autopulse multi-chemistry battery charger (mcc).Four green led lights were lit after unsuccessful charging attempt.The battery was also tested in a known good autopulse platform and the battery failed to power up the platform, thus confirming the reported complaint.The battery archive data review showed battery mismanagement and charging practice by the customer.The customer let the battery remain in the autopulse platform for an extended period of time and was discharged below its minimum operating voltage.The autopulse power system user guide states: "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 li-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 display any led status lights and will fail charging.We noticed that battery was not maintained per user guide.Educated the customer by sending a letter with investigation findings and by providing a copy of the autopulse power system user guide.

• 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: 9037166
• MDR Text Key: 158811617
• Report Number: 3010617000-2019-00798
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• PMA/PMN Number: D163369
• 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: 09/19/2019

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: MODEL 100
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1