MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-1773A; BEDSIDE MONITOR, NK SPO2

Model Number	BSM-1773A
Medical Device Problem Codes	Output Problem (3005); Power Problem (3010); Complete Loss of Power (4015)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that their bedside monitor (bsm) displayed "input unit failure" during a procedure.The customer also reported that after they replaced the input unit, their bsm audibly alarmed and displayed a blue screen with error codes, after which it shut down all together.No harm or injury reported.They will be sending this unit in for an exchange.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 model information: an input unit was used in conjunction with the bsm, and is the device that experienced failure.Attempts to obtain the following information were made, but not provided: input unit: model: ni, s/n: ni.Approximate age of the device: no serial number was provided, so the age of the device is unknown.Device manufacturer date: ni, unique identifier (udi) #: ni.
Event or Problem Description
The customer reported that their bedside monitor (bsm) displayed "input unit failure" during a procedure.The customer also reported that after they replaced the input unit their bsm audibly alarmed and displayed a blue screen with error codes, after which it shut down all together.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the bedside monitor (bsm) displayed an "input unit failure" error message during a patient procedure.The customer also reported that after they replaced the input unit, the bsm audibly alarmed and displayed a blue screen with error codes, after which it shut down all together.No patient harm was reported.Investigation summary: the customer indicated they had docked the bsm-1700 to another device but the issue persisted.The complaint unit was returned and was evaluated by nihon kohden repair center (nk rc).Nk rc was unable to observe/duplicate the reported issue.The reported issue could not be confirmed.A review of the history of the serial number identified no similar events.Based on the available information, a definitive root cause could not be identified.The customer was provided with an exchanged unit.
Event or Problem Description
The customer reported that the bedside monitor (bsm) displayed an "input unit failure" error message during a patient procedure.The customer also reported that after they replaced the input unit, the bsm audibly alarmed and displayed a blue screen with error codes, after which it shut down all together.

• Brand Name: BSM-1773A
• Common Device Name: BEDSIDE MONITOR, NK SPO2
• 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, tokyo 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 9709096
• Report Number: 8030229-2020-00087
• Device Sequence Number: 14321248
• Product Code: MHX
• UDI-Device Identifier: 04931921111956
• UDI-Public: 4931921111956
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023
• Report Date (Section F): 02/13/2020

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-1773A
• Device Catalogue Number: BSM-1773A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/27/2020
• Device Age: 46 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INPUT UNIT; INPUT UNIT
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/13/2020