MAUDE Adverse Event Report: NIHON KOHDEN CORP. BSM-6300; VITAL SIGN MONITOR

Model Number BSM-6300

Device Problem Radiofrequency Interference (RFI) (2314)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2015

Event Type  malfunction  

Event Description

The customer reported that wlan recently installed to support the bedside vital sign monitor (b)(6) is causing an issue with their ascom system.Reference mfr #: 8030229-2015-00210.

• Brand Name: BSM-6300
• Type of Device: VITAL SIGN MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORP.
• Manufacturer (Section G): NIHON KOHDEN AMERICA, INC.; 90 icon st.; foothill ranch CA 92610 1601
• Manufacturer Contact: 90 icon st.; foothill ranch, CA 92610-1601
• MDR Report Key: 5005237
• MDR Text Key: 23161606
• Report Number: 2080783-2015-00210
• Device Sequence Number: 1
• Product Code: MHX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BSM-6300
• Device Catalogue Number: MU-631RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1