MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION MU-110A; MAIN UNIT FOR THE PSG-1100

Model Number	MU-110A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)
Health Effect - Clinical Codes	Blister (4537); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that on 11/06/2023 they had another occurrence of the pulse oximeter (spo2 finger probe) leaving skin blisters on the patient finger.The issue is not for the psg-1100a system itself, and is for accessory spo2 probe being used with the system.Other related tickets: 300337771, 300337766, 300340025, 300340026 - different third party probe being used.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 device information: d10 concomitant medical device.The following device was used in conjuction with the psg-1100a system and was the probe that failed: spo2 probe model: tl-631t3 / p311c sn: ni device manufacturer date: ni unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.
Event or Problem Description
The customer reported that on 11/06/2023 they had another occurrence of the pulse oximeter (spo2 finger probe) leaving skin blisters on the patient finger.Other related tickets: 300337771, 300337766, 300340025, 300340026 - different third party probe being used.
Additional Manufacturer Narrative
Details of complaint: the customer reported that they had 5 separate occurrences of the pulse oximeter (spo2 finger probe) leaving skin blisters on the patient's finger.This report is to document the occurrence dated 11/06/2023.There was no issue with the psg-1100a system itself.The issue was reported to be with the spo2 probe accessory used with this psg system.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.The customer was contacted for the return of the device, but these requests were left unanswered.The customer reported that the probe was attached to the same site for 7 hours 30 min.A possible cause may include user error with device set-up for the patient's condition.The tl-631t3 operator's manual states that the maximum attachment time for one measurement site is 8 hours, however, the measurement site should be checked and changed more frequently for patients with certain conditions such as sensitive skin or poor blood circulation.Prolonged attachment of the spo2 probe at the same site may cause skin problems for patients with these conditions.The spo2 probe should also not be used on patients undergoing photodynamic therapy or magnetic resonance exams.Blisters forming with the use of the device have only been reported from duke university medical center.As such, it may be likely that the probes were placed on the patients' fingers incorrectly.Pinching and friction are also a common cause of blisters.If the sensor is too loose or too tight on a patient's finger, it may result in a blister.The operator's manual for the probe contains warnings that warn to take extreme care when removing the probe and attachment tape from the patient, and to check the blood circulation condition by observing the skin color and condition at the skin peripheral to the probe attachment site.The following related complaints were reported in separate mdrs: (b)(4) - a different probe was in use.(b)(4)- a different probe was in use.(b)(4) - a different probe was in use.(b)(4) - a different probe was in use.Additional device information: d10 concomitant medical device.The following device was used in conjuction with the psg-1100a system and was the probe that failed: reusable spo2 probe: model: tl-631t3 / p311c.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H11 additional manufacturer narrative.
Event or Problem Description
The customer reported that they had 5 separate occurrences of the pulse oximeter (spo2 finger probe) leaving skin blisters on the patient's finger.This report is to document the occurrence dated 11/06/2023.
Additional Manufacturer Narrative
Corrected information: d1 brand name: corrected the brand name from psg-1100a to mu-110a.D4 additional device information / model #: corrected the model # from psg-1100a to mu-110a.D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (pi) information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.
Event or Problem Description
The customer reported that that they had 5 separate occurrences of the pulse oximeter (spo2 finger probe) leaving skin blisters on the patient's finger.This report is to document the occurrence dated (b)(6) 2023.

• Brand Name: MU-110A
• Common Device Name: MAIN UNIT FOR THE PSG-1100
• 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: 18378753
• Report Number: 8030229-2023-03947
• Device Sequence Number: 7579750
• Product Code: GWQ
• UDI-Device Identifier: 04931921108437
• UDI-Public: (01)04931921108437
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K120888
• 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,Followup
• Report Date (Section B): 08/16/2024

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: MU-110A
• Device Catalogue Number: MU-110AK
• 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: 11/24/2023
• Supplement Date Received by Manufacturer: 03/08/2024; 03/08/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/13/2024; 08/20/2024
• 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: SPO2 PROBE; SPO2 PROBE; TL-631T3 / P311C
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown