|
Maxtec's investigation: the micromax air-oxygen blender dispenses a continuous and precise blend of medical air and usp oxygen via outlet ports to infant, pediatric and adult patients.The blender is to be used by trained, qualified medical personnel under the direct supervision of a licensed physician.Maxtec was notified of the incident on november 27, 2019 and notified the blender supplier.The product was requested back for further evaluation and investigation.The device was not returned to maxtec or to our supplier.The investigation was conducted via a review of documentation provided by the customer, phone interviews with maxtec's customer, and a review of product complaint history.The reported incident identified that the blender caught fire during installation causing a superficial burn to the dealer.In addition, the final complaint report provided by our customer included the following observations: air from compressor was introduced first and oxygen later from a cylinder.The output pressure of air was 3.5 in compressor.The oxygen was not observed.During onsite visit, no standard procedures followed for opening cylinder and no one in the department is trained.Observed pressure gauge/regulator connected on cylinder was faulty.Without any input flow, the output flow pressure was displaying 12+ kg/cm2.O the same was shown (to the facility doctor) dr.(b)(6), who denied to accept the same stating that it could be due to the blast.The review of the instructions for use on the micromax, confirmed that there is a caution statement identifying that when using a bottled high pressure gas source, always use a pressure reducing regulator set within 30-75 psi (2.1 - 5.2 bar).From the information provided by our customer as stated above, the regulator was outside of the allowable range.Because the device was not returned and the observation was made after the event, maxtec was unable to determine if this was the root cause of the incident.The date of manufacture for the device in question was december 3, 2018.Maxtec's complaint database was reviewed for the january 01, 2017 to november 13, 2020 date range.No additional complaints reported involved incidents relating to fire.Root cause: based on the absence of the defective sample for evaluation, and no like complaints, the investigation results were inconclusive.The incident's root cause was undetermined however there is no information available to suggest that the root cause was related to the maxtec micromax.Corrections / corrective actions.No actions were determined to be necessary as the root cause was undetermined and no additional complaints or incident reports have been received.Additional narrative/data.Maxtec was originally made aware of this incident on november 27, 2019.Although the product was unavailable for return an investigation was performed and maxtec notified the supplier.On october 22, 2020, a review of adverse occurrences conducted by the new vp of quality and regulatory affairs uncovered that the adverse event had not been filed with the us fda.An mdr evaluation was conducted in accordance with us fda 21cfr part 803.It was determined that a 30-day report to the fda was warranted based on the details of the incident.The date of awareness for this purpose was october 22, 2020.The event was reported to the fda by the supplier on 12/20/2019 via report #: 2523148-2019-00002.The following results from the maude database, product code bzr, date range january 01, 2008- november 06, 2020: there were a total of 266 reportable events.2 out of 266 of the events pertained to fire related incidents.1 of the 2 events was the supplier reporting this event via report #: 2523148-2019-00002.The second event did not involve maxtec labeled product.In addition, the two incidents occurred greater than 12 months apart.
|
|
Description of the event as given to maxtec via customer complaint."on 26th nov, our vendor was in nicu dept for installation of bubble cpap with maxtech max blender, after installation , vendor was having final checking or trial of proper functioning of cpap device, with a flow of 10 litre.Suddenly the blender got burst with fire.There was no injury to hospital staff or patient.Our channel partner (mr.(b)(6) met with a superficial burn of his left hand and he got immediately first aid treatment from the hospital." the customer provided additional details regarding the event via report ps: (b)(4) stating the following: "while installing the bubble cpap set up and upon connecting the blender, the dealer switched on the compressor and the hospital ward boy opened the o2 cylinder.Within no time, the blender started alarming continuously and fire was observed at the top and bottom of the blender.Immediately, the dealer disconnected all connections turning the o2 cylinder off.During this procedure, the dealer was left with a minor burn on his shoulder.".
|
