MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-1753A; VITAL SIGNS MONITOR

Model Number BSM-1753A

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

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

Event Date 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

The senior enterprise risk manager from the facility reported that while attempting to attach leads to an actively seizing patient, the patient transport module of the monitor became dislodged from its seat and fell and struck the patient near the eye.Their investigation determined that caregivers have experienced other instances where they believe that the transport module was properly seated; however, it becomes dislodged.The feedback from them is that it is not easy to tell if the module is fully seated and locked in due to the location of the transport module.It is also difficult to align the clips.The patient sustained a 2 cm laceration and contusion near the eye.They noted that it was not life threatening.The injury did not necessitate medical or surgical intervention to preclude permanent impairment, and there was no permanent impairment or damage to the body structure.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.

Event Description

The senior enterprise risk manager from the facility reported that while attempting to attach leads to an actively seizing patient, the patient transport module of the monitor became dislodged from its seat and fell and struck the patient near the eye.Their investigation determined that caregivers have experienced other instances where they believe that the transport module was properly seated; however, it becomes dislodged.The feedback from them is that it is not easy to tell if the module is fully seated and locked in due to the location of the transport module.It is also difficult to align the clips.The patient sustained a 2 cm laceration and contusion near the eye.They noted that it was not life threatening.The injury did not necessitate medical or surgical intervention to preclude permanent impairment, and there was no permanent impairment or damage to the body structure.

Event Description

The senior enterprise risk manager from the facility reported that while attempting to attach leads to an actively seizing patient, the patient transport module of the monitor became dislodged from its seat and fell and struck the patient near the eye.Their investigation determined that caregivers have experienced other instances where they believe that the transport module was properly seated; however, it becomes dislodged.The feedback from them is that it is not easy to tell if the module is fully seated and locked in due to the location of the transport module.It is also difficult to align the clips.The patient sustained a 2 cm laceration and contusion near the eye.They noted that it was not life threatening.The injury did not necessitate medical or surgical intervention to preclude permanent impairment, and there was no permanent impairment or damage to the body structure.

Manufacturer Narrative

Details of the complaint: the senior enterprise risk manager from the facility reported that while attempting to attach leads to an actively seizing patient, the patient transport module of the monitor became dislodged from its seat and fell and struck the patient near the eye.Their investigation determined that caregivers have experienced other instances where they believe that the transport module was properly seated; however, it becomes dislodged.The feedback from them is that it is not easy to tell if the module is fully seated and locked in due to the location of the transport module.It is also difficult to align the clips.The patient sustained a 2 cm laceration and contusion near the eye.They noted that it was not life threatening.The injury did not necessitate medical or surgical intervention to preclude permanent impairment, and there was no permanent impairment or damage to the body structure.Investigation conclusion: the customer reported that they could not provide the serial number of the bsm-1700.From the adverse event form, the customer reported that unit was not available for evaluation since they were unsure of the exact transport module that fell.Their biomed inspected the unit and determined that it operated as expected after the event.A definitive root cause could not be determined since the device was not available for evaluation.Possible cause may include user error with device set-up such as use of an unspecified stand/cart, installing the unit above the patient, incorrect docking of the input unit, or inadequate cable organization.The bsm-1700 operator's manual includes instructions, warnings, cautions on how to set up the device to avoid dropping the unit.Review of the customer's complaint history does not show recurrence or other similar complaints.

• Brand Name: BSM-1753A
• Type of Device: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochiai; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN 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: 18066195
• MDR Text Key: 327295621
• Report Number: 8030229-2023-03851
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921111871
• UDI-Public: 4931921111871
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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-1753A
• Device Catalogue Number: BSM-1753A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: BEDSIDE MONITOR; BEDSIDE MONITOR
• Patient Age: 70 YR
• Patient Sex: Female