Catalog Number CA25K0/400/000JP |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a pre-test a leak occurs.Patient involvement unknown.
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Manufacturer Narrative
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Other, other text: b3: month and year of event have been provided; day is unknown.D4: expiration date and h4: manufacture date is unknown; no information is available based on reported lot number.D4.Udi number is unknown, no information has been provided to date.G5: 510k is blank device is exempt.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Manufacturer Narrative
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One device was returned.Visual inspection revealed no abnormalities such as damage related to the reported event.A leak test was performed and leakage from the breathing circuit was confirmed.The complaint was confirmed.No other anomaly was observed.A root cause was not established however it was believed the leakage occurred before being supplied to the distribution facility.A device history record (dhr) review found no discrepancies or anomalies in the reported lot number.The device was sent to the manufacturing site for further device analysis.
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Manufacturer Narrative
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H6 codes updated.Device evaluation.One device was returned for investigation without original packaging.Device was visually inspected where no apparent defects were found.Functional testing was done where no device issue was found, customer complaint was not confirmed.Device history review of the reported lot number showed no non-conformities of the reported lot number during the manufacturing process.
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Search Alerts/Recalls
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