MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION PSG-1100A; POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH

Model Number PSG-1100A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)

Patient Problems Blister (4537); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2023

Event Type  malfunction  

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 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.

• Brand Name: PSG-1100A
• Type of Device: POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH
• 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
• MDR Text Key: 331377403
• Report Number: 8030229-2023-03947
• Device Sequence Number: 1
• Product Code: GWQ
• UDI-Device Identifier: 04931921108437
• UDI-Public: 04931921108437
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120888
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PSG-1100A
• Device Catalogue Number: MU-110AK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TL-631T3 / P311C
• Patient Outcome(s): Required Intervention