MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-02 for ENSOETM REF ECD02-A manufactured by Attune Medical.
[90970392]
Pt. Had an esophageal cooling device; machine for the esophageal cooling device had to get refilled twice throughout the morning; after the machine was alarming to have fluid replaced again, the esophageal probe was pulled out from the patient; it was discovered that the very end of the probe had 2 holes in it allowing water to be administered to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073086 |
| MDR Report Key | 6995802 |
| Date Received | 2017-11-02 |
| Date of Report | 2017-10-30 |
| Date of Event | 2017-10-25 |
| Date Added to Maude | 2017-11-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENSOETM |
| Generic Name | ESOPHAGEAL COOLING DEVICE |
| Product Code | PLA |
| Date Received | 2017-11-02 |
| Model Number | REF ECD02-A |
| Lot Number | 199119417B |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ATTUNE MEDICAL |
| Brand Name | ENSOETM |
| Generic Name | ESOPHAGEAL COOLING DEVICE |
| Product Code | PLA |
| Date Received | 2017-11-02 |
| Model Number | REF ECD02-A |
| Lot Number | 199119417B |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTUNE MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-02 |