MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEDINA SPECTRUM WIRELESS BATTERY MODULE

Model Number N/A

Device Problem Charred (1086)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Baxter received and evaluated the device.A device history review revealed no issues that could have caused or contributed to the reported issue.The reported condition was verified.The device was found out of specification in relation to the reported charred printed circuit board (pcb).Internal visual inspection found that the radio pcb had corroded and failed due to fluid intrusion.The unit was determined to be not repairable and was retired from service.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the printed circuit board of a spectrum wireless module was charred.There was no patient involvement.No additional information is available.

• Brand Name: SPECTRUM WIRELESS BATTERY MODULE
• Type of Device: BATTERY
• Manufacturer (Section D): BAXTER HEALTHCARE - MEDINA; medina NY
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDINA; 711 park ave; medina NY 14103
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6930917
• MDR Text Key: 89952050
• Report Number: 1314492-2017-02171
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/09/2017

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 35162
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2017
• Initial Date FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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