|
Model Number 50000000E |
Device Problem
Biocompatibility (2886)
|
Patient Problems
Chills (2191); Discomfort (2330); No Code Available (3191)
|
Event Date 11/26/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
|
|
Event Description
|
It was reported that the patient developed pneumonia after developing breathing difficulties overnight.It was also reported that the arctic sun device did not malfunction, but rather made the patient uncomfortable and following the protocol could not ease the patient's discomfort.The patient was removed from the arctic sun device but the patient continued to shiver slightly for the next 48 hours.Warm blankets were applied and the patient was also treated for fever with schedules tylenol.It was also reported that cefepime, vancomycin, tylenol, and fentanyl, were administered for respiratory distress.Therapy was not completed on the device.
|
|
Manufacturer Narrative
|
The reported issue was unconfirmed.The root cause of the reported issue could not be determined as the reported issue could not be reproduced.It was found that the device was working properly.No repairs were made to the device for the reported issue.The control panel coin cell was replaced.It is unknown if the device was influenced by the reported failure, however the device met specifications for the reported issue during evaluation.The device was being used for treatment at the time of the reported event.Bmd investigation indicates that the reported issue was unconfirmed.Therefore the labeling and dhr review is not required.Corrections: d,h h11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the actual/suspected device was evaluated.
|
|
Event Description
|
It was reported that the patient developed pneumonia after developing breathing difficulties overnight.It was also reported that the arctic sun device did not malfunction, but rather made the patient uncomfortable and following the protocol could not ease the patient's discomfort.The patient was removed from the arctic sun device but the patient continued to shiver slightly for the next 48 hours.Warm blankets were applied and the patient was also treated for fever with schedules tylenol.It was also reported that cefepime, vancomycin, tylenol, and fentanyl were administered for respiratory distress.Therapy was not completed on the device.
|
|
Search Alerts/Recalls
|
|
|