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

Model Number BSM-1753A

Device Problems Output Problem (3005); Power Problem (3010); Complete Loss of Power (4015)

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

Event Date 01/03/2024

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the bedside monitor (bsm) is turning off.It was also having issues where the spo2 stops working.They were able to duplicate both issues.There was some damage to the unit, but they already replaced the front panel and screen.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the bedside monitor (bsm) is turning off.It was also having issues where the spo2 stops working.They were able to duplicate both issues.There was some damage to the unit, but they already replaced the front panel and screen.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.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2 - a6.B6 - b7.D10 concomitant medical device.Attempt #1 (b)(6) 2024 emailed customer via microsoft outlook for all items under the no information section.The customer responded back, but they did not provide the patient and additional device information as requested.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) was powering off.Additionally, the spo2 had stopped working.There was also some physical damage and the customer had already replaced the front panel and display screen.No patient harm or injury was reported.Investigation summary: the device was sent in for evaluation and repair.Nihon kohden repair center (nk rc) was able to observe and duplicate the reported issue.Nk rc found that the device had internal and external physical damage.The front case of the device was damaged.The connector of ecg, dpu-pcb to the power pcb was damaged and the connection was no longer secure.The damage to this part was causing the power issue.Nk rc indicated that this kind of damage is caused by dropping the device or by the introduction of some external force and is unlikely to happen with normal use of the device.Physical damage to the device could also affect the functions of the device (such as spo2 function).Based on the available information, the cause of the issue is device mishandling.Physical damage to the device may be due to device mishandling, strong impact on the device (i.E.Device drop), and wear and tear.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, screen overlays, ports, ac cradles, adapters, cases, display screens, or other external features may result due to impact or wear and tear.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 ingression may also result in device failure.Some device damage may occur to internal components (e.G., module boards, button housings, internal connections) and not be immediately evident to users.The following fields contains no information (ni), as attempts to obtain the information were made, but not provided: attempt #1 01/05/2024 emailed customer via microsoft outlook for all items under the no information section.The customer responded, but did not provide the requested information.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h11 additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the bedside monitor (bsm) was powering off.Additionally, the spo2 had stopped working.No patient harm was reported.

• Brand Name: BSM-1753A
• 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 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: 18615683
• MDR Text Key: 334801581
• Report Number: 8030229-2024-04053
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2018
• 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