Catalog Number 100/890/080 |
Device Problems
Inflation Problem (1310); Unintended Deflation (4061)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/18/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Other, other text: d4: lot number, expiration date and h4: manufacture date are unknown.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.
|
|
Event Description
|
It was reported that the bedside nurse found the patient's tracheostomy tube cuff had gone down to 10cm of h20 at the beginning of her shift.She needed to re-inflate it back to 30cm of h20.Patient was involved, no patient injury or adverse effects reported.Patient information is not available.Trach team consultant performed cuff pressure check and re-inflated back to appropriate level.Cuff was re-checked after an hour and leak was confirmed.Patient was fasted and an urgent tracheostomy change was performed by icu consultant.
|
|
Manufacturer Narrative
|
Evaluation codes: updated device evaluation: one device was returned for investigation.Under visual inspection the sample appeared to be in good condition.Functional testing confirmed that after 12 hours the cuff was still fully inflated.Based on results of testing the reported failure was not observed or confirmed.No lot number was provided, therefore no device history report (dhr) review could be performed.No trend of similar customer complaints was identified.
|
|
Search Alerts/Recalls
|