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 07/10/2023

Event Type  Injury  

Manufacturer Narrative

The customer reported that that they had 4 separate occurrences of the pulse oximeter (spo2 finger probe) leaving skin blisters on patient finger.This is for the (b)(6) 2023 occurrence.The issue is not for the psg-1100a system itself, and is for accessory spo2 probe being used with the system.Other related complaints will be reported: (b)(4) different probe model 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.Attempt #1 (b)(6) 2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 (b)(6) 2023 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 patient and additional device information as requested.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 that they had 4 separate occurrences of the pulse oximeter (spo2 finger probe) leaving skin blisters on patient finger.This is for the (b)(6) 2023 occurrence.The issue is not for the psg-1100a system itself, and is for accessory spo2 probe being used with the system.Other related complaints will be reported: (b)(4).Different probe model being used.

Event Description

The customer reported that that they had 4 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.

Manufacturer Narrative

Details of complaint: the customer reported that that they had 4 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.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 return shipping label for this event does not indicate the customer has shipped the item to us.A complaint history review of the device does not reveal similar complaints from other customers.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 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 congestion at the skin peripheral to the probe attachment site.The following related complaints were reported separately: 300337771 - a different probe model was in use.300340025 - a different probe model was in use.300340026 - a different probe model was in use.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2 - a6.B6 - b7.D4 serial number.H4.Attempt #1 (b)(6) 2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 (b)(6) 2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded with complaint details, but did not provide the requested information.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.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Additional information: b4 date of this report.D10 concomitant medical device.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H10 additional manufacturer narrative.

• 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: 17561697
• MDR Text Key: 321308649
• Report Number: 8030229-2023-03727
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• 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: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SPO2 PROBE; TL-631T3 / P311C
• Patient Outcome(s): Required Intervention