MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-2354A; VITAL SIGNS MONITOR

Model Number	BSM-2354A
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Stops Intermittently (1599); Intermittent Loss of Power (4016)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that this bedside monitor (bsm) was powering off/on by itself.The customer checked and reseated the power cable and replaced the battery.Customer included that the front enclosure is cracked.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 or Problem Description
The customer reported that this bedside monitor (bsm) was powering off/on by itself.
Additional Manufacturer Narrative
Details of complaint: on (b)(6) 2017, the customer at (b)(6) reported the following issue with bsm-2354a; sn (b)(4), from patient monitoring: the bedside monitor was powering off/on by itself.Customer tried a new power supply, made sure the power cable was fully plugged in on both ends and replaced the battery, but the issue persists.Service requested: repair/loaner.Service performed: initial troubleshooting done on (b)(6) 2017 revealed that the bsm's front enclosure was cracked.He wanted to send this in for repair and needed a loaner, but the device was never received by nk.On 12/08/2017 a loaner was shipped to the customer, which was received back on 01/05/2018.The defective device was never evaluated by nk.Investigation summary: the root cause of the issue could not be determined because defective device was never received by nk for evaluation.However, there was found to be user error/physical damage.Based on the given information, this complaint record can be closed as no further investigation is needed at this time.
Event or Problem Description
The customer reported that this bedside monitor (bsm) was powering off/on by itself.

• Brand Name: BSM-2354A
• Common Device Name: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7031537
• Report Number: 8030229-2017-00401
• Device Sequence Number: 11081392
• Product Code: MHX
• UDI-Device Identifier: 04931921101728
• UDI-Public: 04931921101728
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K011918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020
• Report Date (Section F): 11/14/2017

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
• Operator of Device: Health Professional
• Device Model Number: BSM-2354A
• Device Catalogue Number: BSM-2354A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/16/2017
• Device Age: 118 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/14/2017