MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BLUPRO; SPO2 PROBE

Model Number	TL-271T3
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the patient was wincing in pain and guarding the finger with the pulse oximeter probe on it.Upon removal of the device, there was a blister where the device had been, and the finger was warm and red with slight edema.
Additional Manufacturer Narrative
The customer reported that the patient was wincing in pain and guarding the finger with the pulse oximeter probe on it.Upon removal of the device, there was a blister where the device had been, and the finger was warm and red with slight edema.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 date of birth.B1 date of event - the customer noted 11/2024 and the actual date of event is unknown.B6 relevant test / laboratory data.B7 other relevant history.D4 lot number.D10 concomitant medical device.H4 device manufacturer date.Attempt #1: 11/26/2024 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the additional device or some of the patient information as requested.
Additional Manufacturer Narrative
Details of the complaint: customer reported that a patient was wincing in pain and is guarding the finger with the pulse oximeter probe.Upon removal of the device, a blister could be seen on the patient's finger.The finger was also warm and red with slight edema.Customer was monitoring pulse oximetry of the patient.Investigation conclusion: on a follow-up with customer, customer stated that they do not know the specifics of the resolution of the issue but stated that their nursing and biomed departments addressed / changed some settings in their system.Customer stated that the ticket could be closed.The complaint unit is not available for evaluation.Without evaluation of the complaint unit, a definitive root cause could not be identified.A review of the tickets on part tl-271t3-a24 (complaint unit) found no other reports leading to a blister or any other harm to the patient.The reported issue is an isolated incident.Possible causes of the issue are prolonged or improper use of the probe, tight application and improper placement of the probe.Patient's skin type and condition may also contribute to the issue.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.B1 date of event - the customer noted 11/2024 and the actual date of event is unknown.Attempt #1 (b)(6) 2024 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the additional device or some of the patient information as requested.
Event or Problem Description
The customer reported that the patient was wincing in pain and guarding the finger with the pulse oximeter probe on it.Upon removal of the device, there was a blister where the device had been, and the finger was warm and red with slight edema.

• Brand Name: BLUPRO
• Common Device Name: SPO2 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: 20865518
• Report Number: 8030229-2024-04592
• Device Sequence Number: 8838957
• Product Code: MHX
• UDI-Device Identifier: 14931921878535
• UDI-Public: (01)14931921878535
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K213316
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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-271T3
• Device Catalogue Number: TL-271T3
• 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: 11/21/2024
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White