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Catalog Number 8400 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Calibrate (2440)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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It was reported that the device's carbon monoxide (c02) readings are not accurate and the unit will not calibrate.Patient involvement is unknown.
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Manufacturer Narrative
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Other, other text: b3: date of event is unknown, no information has been provided to date.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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Event Description
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Additional information received via email."the request was cancelled with reference ps ref 6919712.No further details provided".
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Manufacturer Narrative
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One device was received.Per visual inspection, battery compartment cracked, no flowrate reading.Loose screws and speaker inside, screw and nut were missing.Co2 pump was dislodged.The battery door foam was torn half off and nafion tube was contaminated.Per functional testing, the monitor would not power on due to the cracked battery compartment.Held battery compartment closed and monitor powered up, but no reading on flow rate?.The complaint was confirmed.The root cause was disconnected co2 tubing as a result of physical impact sustained by the monitor during use and handling.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Reassembled disconnected parts.Replaced the nafion tube for preventative maintenance (pm).Replaced restrictor to adjust the flowrate and replaced battery door foam.Device passed all functional and delivery tests.
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Search Alerts/Recalls
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