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)

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

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the bedside monitor (bsm) appears to have fallen off the gcx mount and landed on the top left section, crushing the monitor.The 4 mounting screws that hold the plate to the bottom of the monitor came loose and fell out of the pims.Not in patient use.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.The following fields are not applicable (na) to the mdr report: a2 - a6 b2 b6 - b7 d4 lot number & expiratio.N d6a - d6b d7b f1 - f14 g4 device bla number g5 g7 h2 h7 h9 additional device information: d10: concomitant medical device: the following device(s) were being used in conjunction with the bedside monitor (bsm).Gcx monitor mount.Model: nk0031s2b.Sn: (b)(6).Manufacturer: gcx.

Event Description

The biomedical engineer (bme) reported that the bedside monitor (bsm) appears to have fallen off the gcx mount and landed on the top left section, crushing the monitor.The 4 mounting screws that hold the plate to the bottom of the monitor came loose and fell out of the pims.Not in patient use.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) had fallen off the gcx mount and landed on the top left section, crushing the monitor.The 4 mounting screws that hold the plate to the bottom of the monitor came loose and fell out of the pins.The device was not in patient use.Investigation summary: the reported device was sent in for evaluation and repair, and the issue a was duplicated and confirmed.Upon inspection from repair center, they found the front enclosure had some damage, the lcd was bent along the top of it.Also, the power supply sustained damage.But based on the available information, the most probable root cause of the unit falling off the mount could have been caused by improper installation or using the incorrect mount or screws.Unfortunately, it is difficult to determine a definitive root cause.To resolve the issue, an exchange unit (mu-631ra, sn: (b)(6)) was shipped to the customer.The bedside monitor is designed to be mobile and travel with the patient during transport.The possibility of impact is greatly increased in these devices because of their mobile status.Impact to the device can result in tangible damage to the device that can affect the use of the device, whether caused by accident or otherwise.Exterior damage to handles, cases, cords, ports, ac cradles, adapters, cases, display screens, or other external features may result due to impact.Excessive force applied to the bsm case because of falling off a wall or stand during relocation of the device or during transport may result in damage to the internal components like the pump, dpu, power bd, digital bd, and device mainboards and could lead to failure of the device.The bsm is neither shockproof nor waterproof, and water or other fluid ingress may also result in device failure.Excessive force on external surfaces and buttons can damage not only the external elements but also internal printed circuit boards and other components, which may cause startup failure.A serial number review of the reported device (mu-631ra, sn: (b)(6) and gcx mount) does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.Nk will continue to monitor and trend similar complaints.Additional device information: d10: concomitant medical device: the following device was used in conjunction with the bedside monitor (bsm): gcx monitor mount: model: nk0031s2b.Sn: ni.Manufacturer: gcx.

Event Description

The biomedical engineer (bme) reported that the bedside monitor (bsm) had fallen off the gcx mount and landed on the top left section, crushing the monitor.The 4 mounting screws that hold the plate to the bottom of the monitor came loose and fell out of the pins.The device was not in patient use.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18540881
• MDR Text Key: 333482377
• Report Number: 8030229-2024-04043
• 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: 04/02/2024

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: 01/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2015
• 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: GCX MONITOR MOUNT; GCX MONITOR MOUNT