|
Devilbiss healthcare was notified of an incident involving an oxygen concentrator by the provider who stated that the device became heated, causing the sieve beds to fail and the compressor box to warp.There was no report or evidence of illness, serious injury or medical treatment associated with the complaint.The device was returned for evaluation.Upon evaluation, the thermal event was limited to the compressor box and intake filter, with slight damage to the rear cover, at the intake filter cut-out.Evidence of mishandling was observed in that multiple screw bosses were cracked and one of the wheel bosses was damaged.The fan and alarm system were both found to be working correctly, however the thermal cut-off within the compressor was inoperable.The unit had evidence of being repaired even though there were no previous repair records for this unit.The manifold was found to be a high-pressure manifold, instead of a low-pressure manifold and the hose from the right sieve bed to the manifold was incorrectly routed.The serial number on the valve did not match the serial number of the valve in the unit dhr.The compressor was found to be missing the serial number sticker, so it is unclear if the compressor was the original compressor built into the unit.It appears that unauthorized service was provided to the unit using unauthorized replacement parts possibly contributing to the malfunction of the unit.The root cause of the thermal event cannot be determined with certainty with the information and evidence provided.The inoperable compressor thermal cut-off (tco) device may have contributed to the extent of the thermal damage but was not likely the root cause for the thermal event.It is not clear if the tco was damaged during the prior servicing.Since the alarm system was functioning properly and multiple high gas temperature errors were logged, the user would have been alerted to the high temperature failure mode.
|