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

Model Number BSM-6301A

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2021

Event Type  malfunction  

Event Description

The customer reported that the bedside monitor (bsm) fell from the wall support bracket it was attached to.No harm or injury was reported.

Manufacturer Narrative

The customer reported that the bedside monitor (bsm) fell from the wall support bracket it was attached to.No harm or injury was reported.They sent this unit in for repair on (b)(6) 2022.The handle was damaged and needed replacement.The handle was replaced on (b)(6) 2022 by nihon kohden's repair center (nk rc).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.Additional device information: concomitant medical device: the following device was used in conjunction with the bsm and is the device that experienced the failure: wall support bracket with gcx arm: model #: the customer did not have this information.Serial #: there was no sn on the arm and it is believed to not be a serialize part.

Manufacturer Narrative

Details of complaint: the customer reported that the bedside monitor (bsm) fell from the wall support bracket it was attached to.No harm or injury was reported.They sent this unit in for repair on 01/04/2022.The handle was damaged and needed replacing.The handle was replaced on 04/29/2022 by nihon kohden's repair center (nk rc).The device was not in patient use at the time.No harm or injury was reported.Investigation summary: evaluation of the reported device was not able to confirm the cause of the device falling off the wall mounting.The only physical damage that was observed was the broken handle that was already reported by the customer.The manual for the kg-951 bracket details the proper torque specifications to prevent loosening, damage, or deformation of the screws.It is likely that the customer under torqued the screws, resulting in the screws loosening and the bsm becoming loose from the mounting bracket.The root cause is likely use error.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm and is the device that experienced the failure: wall support bracket with gcx arm: model #: the customer did not have this information.Serial #: there was no sn on the arm and it is believed to not be a serialize part.

Event Description

The customer reported that the bedside monitor (bsm) fell from the wall support bracket it was attached to.No harm or injury was reported.

• 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: 15668477
• MDR Text Key: 306998476
• Report Number: 8030229-2022-03165
• 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: 09/25/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2014
• 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: WALL SUPPORT BRACKET WITH GCX ARM.; WALL SUPPORT BRACKET WITH GCX ARM.