|
Model Number 50000000E |
Device Problem
Insufficient Cooling (1130)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/22/2021 |
Event Type
malfunction
|
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 was not cooling on the arctic sun device from the last night, and hence they swapped out the device for a new one everything appear to be working appropriately.The patient temperature was 37.1c, the target temperature was 37c, the water temperature was 18.6 c and the flow rate was 2.8 lpm with 1 bar trending downward.They tried to get the report of the actual issue with the original device and stated that the patient temperature was 37.6 c and the water temperature was 5 c, but the patient temperature was not dropped.Ms&s explained the complainant would call when the issue was occurring, so they would assist with troubleshooting while the device was still on the patient.It was noted that they would send the device down to biomed for the evaluation and contact to speak with the technical support if additional assistance needed.Per follow-up via nurse on 01feb2021, it was noted the biomed run a functional check on the device, and no issues were found.The device was back in service and thought the previous issue was patient-related.
|
|
Event Description
|
It was reported that the patient was not cooling on the arctic sun device from the last night, and hence they swapped out the device for a new one everything appear to be working appropriately.The patient temperature was 37.1c, the target temperature was 37c, the water temperature was 18.6 c and the flow rate was 2.8 lpm with 1 bar trending downward.They tried to get the report of the actual issue with the original device and stated that the patient temperature was 37.6 c and the water temperature was 5 c, but the patient temperature was not dropped.Ms&s explained the complainant would call when the issue was occurring, so they would assist with troubleshooting while the device was still on the patient.It was noted that they would send the device down to biomed for the evaluation and contact to speak with the technical support if additional assistance needed.Per follow-up via nurse on 01feb2021, it was noted the biomed run a functional check on the device, and no issues were found.The device was back in service and thought the previous issue was patient-related.
|
|
Manufacturer Narrative
|
The reported issue was unconfirmed.No root cause could be found because the reported event was unconfirmed.The patient temperature was 37.1c, the target temperature was 37c, the water temperature was 18.6c and the flow rate was 2.8 l/m with 1 bar trending downward.They tried to get report of actual "issue" with original device and stated that the patient temperature was 37.6c and the water temperature was 5c, but patient temperature was not dropping.Explained the complainant could call when the issue was occurring so that they could assist with trouble shooting while the device was still on the patient.Noted that they should send device down to biomed for evaluation and could contact to speak with technical support if additional assistance needed.Per follow up, noted the biomed had ran a functional check on it on the floor this morning and no issues were found.The device was back in service and thought the previous issue was patient-related.It is unknown if the device was influenced by the reported failure, however the device met specifications during evaluation.The device was use on a patient.A dhr review was not required as the investigation was unconfirmed.Therefore, no additional action is required at this time.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not required as the investigation was unconfirmed.H11: section a through f - the information provided by bd 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 bd h3 other text : the device was not returned.
|
|
Search Alerts/Recalls
|
|
|