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Update 27th march 2020 update from the account 24th march 2020 the eeg tech was reinterviewed.The patient had reported a "shocking" while having the ambulatory study going.It is now thought that the shocking originated from the patient's reported implanted defibrillaor and not on the scalp as originally reported.The patient's medical record did not have a notation of the defibrillator, but, patient did report having one.The concern is if the device could cause a defibrillator to shock , product manager has been made aware of this and is reviewing.
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Trex hd headbox - felt a strange feeling (burning) on their scalp.The patient stated they felt a strange feeling (burning) on their scalp when our eeg tech was removing the electrodes from this ambulatory study.06 jan 2020 - a list of questions was sent to the complainant to gain more information on the issue.10th jan 2020 a second request to have the questions answered.24 jan 2020 answers received: 1.Was there any death or serious injury? - no.2.Date the event occurred? - (b)(6) 2019.3.Name and title of the person who initially reported the event to natus? - (b)(6) , manager neurodiagnostics dept.At (b)(6).4.List all device being used at the time of event (brand, part descriptions, part numbers, serial numbers, lot numbers etc.): - this was no provided.5.Please provide pictures of the devices involved.- pictures were provided.6.Describe the patient including the patients sex, age and approximate weight- dob: (b)(6) 1945- 74 yo male- 167.6 cm height- 81 kg.7.Have you filed a report to any regulatory agencies regarding this issue? if so, which one(s)? : - i do not know, but, i don't think so.The device was sent for investigation: reported problem confirmed:observations,brocked oxy connector, cracked eeg insert, loose usb connection, cracked dc insert.Replaced: oxy connector, eeg insert, usb port and dc insert.Cleaned and tested, passed all functional tests.21-feb-2020 - repair notes: reported problem was confirmed: observations, brocked oxy connector, cracked eeg insert, loose usb connection, cracked dc insert.Replaced: oxy connector, eeg insert, usb port and dc insert.Cleaned and tested, passed all functional tests.1-feb-2020 - for the past 3 years we reviewed complaints for this failure mode (none found.Currently to date - no more information available.
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Update 27th april 2020 (natus complaint ref.# (b)(4)).Investigation results and findings: risk review: hazard identified in risk file (b)(4) under hazard 9.9 "electrode causes burns to patient".Residual risk associated with this hazard deemed acceptable.Risk-benefit rationale - the hazards identified have been evaluated and found to be in compliance with a known standard.As noted in (b)(4), hazards that have been evaluated and found to be in compliance with known standards can be presumed to be consistent with an acceptable level of risk, yielding an acceptable risk / benefit to the patient or user.Risk outweighed by benefit of use of device.Dhr review details: a dhr review is not applicable because, prior to the reported issue the device was in service for 2 or more years and a manufacturing defect is unlikely.Update from the associated engineering group on the 30th march 2020 indicated that the trexhd user manual does not contain contra-indications for patient carrying a cardiac defibrillator, indicating that there is no risk for the patient.Considering the fact that the recorder is battery powered during the ambulatory study and voltages in the device are low, it is extremely unlikely to interact with the defibrillator in case of an electrical hazard in the device.Typically it can lead to some degree of skin burn.The complaint as reported could not be verified.This issue will be continued to be monitored for future occurrence.
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