Model Number PSG-1100A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)
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Patient Problems
Blister (4537); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
Event Type
Injury
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Event Description
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The customer reported 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; and as they did not provide the day it occurred, we will note it as (b)(6) 2023.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.
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Manufacturer Narrative
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The customer reported 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; and as they did not provide the day it occurred, we will note it as (b)(6) 2023.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.Additional device information: d10 concomitant medical device.The following device was used in "conjunction" 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.
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Event Description
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The customer reported 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.
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Manufacturer Narrative
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Details of complaint: the customer reported 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 01/01/2023.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: 300337766 - 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.Attempt #1 07/25/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 08/11/2023 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: reusable spo2 probe: model: tl-631t3 / p311c sn: ni device manufacturer date: ni unique identifier (udi) #: (b)(4) returned to nihon kohden: not returned.
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