MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6301A; VITAL SIGNS MONITOR

Model Number BSM-6301A

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Output Problem (3005)

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

Event Date 07/20/2022

Event Type  malfunction  

Event Description

The biomedical engineer reported that the lcd / backlight on the bedside monitor went out, and the screen went black.They can press on the screen, and it recognizes touch key presses.They are unable to see anything on the screen.The patient vitals were still being monitored at the central nurse's station (cns).The customer ordered parts to repair the unit.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer reported that the lcd / backlight on the bedside monitor went out, and the screen went black.They can press on the screen, and it recognizes touch key presses.They are unable to see anything on the screen.The patient vitals were still being monitored at the central nurse's station (cns).The customer ordered parts to repair the unit.No patient harm was reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.Attempt #1 (b)(6)2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 (b)(6)2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 (b)(6)2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.Attempt #1 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Event Description

The biomedical engineer reported that the lcd / backlight on the bedside monitor (bsm) went out, and the screen went black.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer reported that the lcd / backlight on the bedside monitor (bsm) went out, and the screen went black.The patient vitals were still seen at the central nurse's station (cns).No patient harm was reported.Investigation summary: alarm and patient monitoring functionality will still be present on the cns.Additionally, patient monitoring can continue at the cns.The device was installed in 11/2010 with no history of repair or additional complaints.As such, it is likely that the root cause of lcd failure is related to wear and tear.As the device was not returned for evaluation, a root cause cannot be determined.The customer wanted to repair the unit in house and nk tech support provided the required part numbers for the customer to order.The unit has no history of lcd issues.

• Brand Name: BSM-6301A
• Type of Device: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 15246329
• MDR Text Key: 304793927
• Report Number: 8030229-2022-03030
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: 04931921103517
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

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-6301A
• Device Catalogue Number: MU-631RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 07/25/2022
• Supplement Dates FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2010
• 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