MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BLUPRO®; SPO2 FINGER OR TOE PROBE

Model Number	TL-631T3
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that three of their tl-0631t3 probes stopped working.According to the customer, the patient had a contact pressure sore.
Additional Manufacturer Narrative
The customer reported that three of their tl-0631t3 probes stopped working.Two of them simply blinked repeatedly before going off and the third one would not turn on at all.According to the customer, the patient had a contact pressure sore.It is unclear if more than one patient was affected by the reported issue.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 field contains no information (ni), as attempts to obtain the information were made, but not provided: d4 serial number & udi d10: attempt # 1: (b)(6) 2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2025 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.Attempt # 3: (b)(6) 2025 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.The following fields are not available (n/a) to this report: h4 device manufacturer date.
Event or Problem Description
The customer reported that three of their tl-0631t3 probes stopped working.According to the customer, the patient had a contact pressure sore.
Additional Manufacturer Narrative
Details of complaint: the customer reported that three of their tl-0631t3 probes stopped working.Two of them simply blinked repeatedly before going off and the third one would not turn on at all.According to the customer, the patient had a contact pressure sore.It is unclear if more than one patient was affected by the reported issue.Investigation summary: the probes were not returned for evaluation; therefore, a root cause could not be determined.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d4 serial number & udi.D10.Attempt # 1: 09/15/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 09/18/2025 i called joseph to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for joseph to call me back with this information.Attempt # 3: 09/19/2025 i called joseph to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for joseph to call me back with this information.The following fields are not available (n/a) to this report: h4 device manufacturer date.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h11 additional manufacturer narrative.

• Brand Name: BLUPRO®
• Common Device Name: SPO2 FINGER OR TOE PROBE
• 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: 23100052
• Report Number: 8030229-2025-05522
• Device Sequence Number: 21003852
• Product Code: MHX
• UDI-Device Identifier: 04931921877494
• UDI-Public: (01)04931921877494
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153707
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TL-631T3
• Device Catalogue Number: TL-631T3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: NI.; NI.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown