[2403677]
The mfr was advised on 02/10/2012 by one of its account managers that a pt had reportedly aspirated a piece of the performatrak full face mask at a user facility. The respiratory manager of the facility stated the pt had been receiving therapy via a b-level positive airway pressure (bipap) device and the mask for six days prior to the discovery of a foreign object in the pt's airway. A bronchoscopy was performed and the facility claims a split ring washer was extracted from the pt's airway (just above the vocal cords). The risk manager of the facility stated that the pt had been admitted with alcohol intoxication, was agitated and confused during the hospital stay, pulling out his feeding tube, and at one point, disassembling the mask. It is unk if the same mask was placed back in use on the pt after the pt disassembled it. The facility claims a foreign object was discovered six days after discontinuing the bipap therapy during the pt? S unrelated second modified barium swallow test. They claim the foreign object removed was a split ring washer from the mask. The reporting facility has discarded the subject mask and therefore it is not available for analysis. However, the facility is in possession of the split ring washer and despite our requests, it has not been made available to the mfr for analysis. Since the mask has been discarded, the lot number of the mask also cannot be determined. There was no serious or permanent injury and the pt was not reported to have any respiratory difficulty as a result of the split ring washer being somehow disconnected from the mask? S elbow assembly. It is unk how long the pt had received bipap therapy using this mask, or how long the split ring washer had been disconnected from the mask. Because the mask could not be evaluated, the mfr reviewed the complaint database for similar reported events, product labeling, and risk analysis for its investigation and notes no adverse events reported for this mask from 01/01/2009 to 02/10/2012. The performatrak disposable full face mask is intended to provide a pt interface for application of noninvasive ventilation. The mask is for single use in the hospital/institutional environment only. The mask is to be used on pts (>30kg) who are appropriate candidates for noninvasive ventilation. Product labeling cautions the user that this mask? Should not be used for pts who are uncooperative, obtunded, unresponsive, have an impaired cough reflex, or are unable to remove the mask. Hand wash prior to first use. Inspect the mask for damage or wear (cracking, crazing, tears, etc). Discard and replace any components as necessary.? The mfr has evaluated the reported incident and determined there is no increased risk of choking associated with this failure mode as the size of the split ring washer is too large to be inspired into the trachea. Since the washers by design have a large hole in the center and very slim profile, the presence of the washer above the vocal cords does not represent an increased risk of asphyxiation. There was no serious or permanent injury reported. Based on this info, and the fact the pt had disassembled the mask, the mfr concludes no further action is appropriate.
Patient Sequence No: 1, Text Type: D, B5