Catalog Number 8884719025 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.A verification of failure mode reported in the current manufacturing process was conducted as follows: 20 devices were taken from the current production p/n 8884719025 voldyne2500 volumetric exerciser lot # 73j1900686, the samples were functionally inspected, and during the test issue reported was not observed in the current manufacturing process.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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Customer reported that during the patient's breathing exercise, the piston moved up but got stuck in the middle of the chamber on the way back down.No patient harm reported.
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Event Description
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Customer reported that during the patient's breathing exercise, the piston moved up but got stuck in the middle of the chamber on the way back down.No patient harm reported.
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Manufacturer Narrative
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Qn#(b)(4).The customer returned one unit 8884719025 voldyne2500 volumetric exerciser for investigation.The returned breathing exerciser was visually examined and no defects or anomalies were observed.A functional inspection was performed on the returned breathing exerciser to simulate use.The exerciser was connected to a vacuum flowmeter to test for movement of the flow cup and piston inside the device.Upon functional inspection, it was found that the flow cup and piston were both able to freely move up and down the device.No functional issues were found.The ifu for this product instructs the end user, "exhale normally.Then place lips tightly around mouthpiece.Inhale slowly to raise the white piston in the chamber.When inhaling, maintain top of the yellow flow cup in the 'best' flow range." "continue inhaling and try to raise piston to prescribed level." the reported complaint of "yellow peg stuck while in use" was not confirmed based upon the sample received.The returned volumetric exerciser was able to pass a functional inspection when connected to a vacuumed air.The flow cup and piston were both able to move freely within the device.A device history record review was performed on the device with no evidence of a manufacturing related issue found.There were no functional issues found with the returned sample.
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Search Alerts/Recalls
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