MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION BSM-6300A; VITAL SIGNS MONITOR

Model Number BSM-6300A

Device Problems Image Display Error/Artifact (1304); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2016

Event Type  Other  

Manufacturer Narrative

The biomedical engineer reports that the bsm (bedside monitor) displays a data send error and a system failure message on the cns (central network station).The error message will persist for about 20 minutes or so and go away and then come back.All waveforms and patient information is still visible.Customer was advised to restart both the cns and the bedside monitor.The cns had not been rebooted for quite some time.Restarting both devices fixed the issue.It was confirmed that power cycling the bedside monitor displayed a "sending data" message rather than the "data send error".Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

Event Description

The biomedical engineer reports that the bsm (bedside monitor) displays a data send error and a system failure message on the cns (central network station).The error message will persist for about 20 minutes or so and go away and then come back.

• Brand Name: BSM-6300A
• Type of Device: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• MDR Report Key: 5654008
• MDR Text Key: 268305179
• Report Number: 2032233-2016-00371
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: 04931921103517
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/30/2016

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: BSM-6300A
• Device Catalogue Number: MU-631RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2016
• Distributor Facility Aware Date: 06/30/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1