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	06/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported that the psg nk rme adult spo2 fingertip probe, caused visible burns to a patient.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: d10 d4 the udi # does not include the sn (pi #), as attempts to obtain the sn were made, but not provided.Attempt # 1: 0708/2026 emailed the customer for the information in the ni list above: on 7/10/2026 they requested a phone call.Attempt # 2: 07/10/2026 called and emailed the customer for the information in the ni list above: the customer stated to call him on mondays.Attempt # 3: 07/13/2026 called multiple times, left a voicemail, and emailed the customer for the information in the ni list above: no reply was received.Attempt # 4: 07/20/2026 called the customer and left a voicemail for the information in the ni list above: no reply was received.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the spo2 finger probe: psg sleep unit / amplifier / junction box.Model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: no.
Event or Problem Description
The customer reported that the psg nk rme adult spo2 fingertip probe, caused visible burns to a patient.

• 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: 25888339
• Report Number: 8030229-2026-06844
• Device Sequence Number: 13299420
• Product Code: MHX
• UDI-Device Identifier: 04931921877494
• UDI-Public: (01)04931921877494
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 07/21/2026

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: 06/26/2026
• Initial Report FDA Received Date: 07/21/2026
• 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: PSG SLEEP UNIT / AMPLIFIER / JUNCTION BOX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Unknown