MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6501A; VITAL SIGNS MONITOR

Model Number BSM-6501A

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Application Program Problem (2880); Output Problem (3005); Unintended Application Program Shut Down (4032)

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

Event Date 01/10/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the bedside monitor (bsm) is constantly rebooting with a blue error.The bme does not know if the unit was in patient use or not.

Manufacturer Narrative

The biomedical engineer (bme) reported that the bedside monitor (bsm) is constantly rebooting with a blue error.The bme does not know if the unit was in patient use or not.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.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that when the unit powers on they could only see the backlight and not the actual screen.The bme does not know if the unit was in paitent use or not.Investigation conclusion: the customer ordered parts to repair the device on their own.The device has been in service since (b)(6) 2009.A review of the history of the serial number identified no similar events.Based on the available information, a definitive root cause could not be identified.A defective display can be caused by electronic failure, power surge, physical damage, and wear and tear.The reported issue has only been a single occurrence on the device.The issue could be resolved by replacing the malfunctioning part.Corrected information: h6 medical device problem codes revised from 2880, 4032 and corrected to 3005, 1184, 1183.Both b5 and h10 narrative have been corrected from the following: the biomedical engineer (bme) reported that the bedside monitor (bsm) is constantly rebooting with a blue error.The bme does not know if the unit was in paitent use or not.Corrected to: the biomedical engineer (bme) reported that when the unit powers on they could only see the backlight and not the actual screen.The bme does not know if the unit was in paitent use or not.

Event Description

The biomedical engineer (bme) reported that when the unit powers on they could only see the backlight and not the actual screen.The bme does not know if the unit was in paitent use or not.

• Brand Name: BSM-6501A
• 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 ; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2-314 ; JA 370-2314
• MDR Report Key: 16345029
• MDR Text Key: 309568073
• Report Number: 8030229-2023-03282
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921103548
• UDI-Public: 04931921103548
• 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: 05/10/2023

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-6501A
• Device Catalogue Number: MU-651RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 05/02/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• 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
• Treatment: NA.; NA.