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

Model Number 8700-0752

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

The autopulse li-ion battery associated with this complaint was not returned for evaluation.Follow-up attempts were made to retrieve the battery; however, were unsuccessful.Since the battery was not returned, an investigation could not be performed and a root cause could not be determined.In the case the battery is returned, the complaint will be re-opened to perform an investigation.

Event Description

During shift check, the autopulse li-ion battery (sn (b)(4)) with 4 green led light illuminated on the battery status indicator was used in the autopulse platform.The platform displayed a "replace battery" message, after replacing the battery, the platform performed as intended.No patient involvement.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7821127
• MDR Text Key: 118400153
• Report Number: 3010617000-2018-00875
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2018

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
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1