MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-03 for ECD (ESOPHAGEAL COOLING DEVICE) manufactured by Advanced Cooling Therapy.
[69344258]
An esophageal cooling system made by advanced cooling therapy leaked while in the patient and caused the patient to choke. There was no harm to the patient but staff still expressed concern about potential aspiration and/or pneumonia risk. Please note that i reported this event earlier today but attributed the event to a different product, sold by a different manufacturer - cryothermic systems. That previous report was in error and i ask that it be withdrawn please. Please do not attribute this problem to cryothermic systems. Reason for use: high fever.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068293 |
| MDR Report Key | 6383530 |
| Date Received | 2017-03-03 |
| Date of Report | 2017-03-03 |
| Date of Event | 2017-02-27 |
| Date Added to Maude | 2017-03-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | ECD (ESOPHAGEAL COOLING DEVICE) |
| Generic Name | ECD (ESOPHAGEAL COOLING DEVICE) |
| Product Code | PLA |
| Date Received | 2017-03-03 |
| Returned To Mfg | 2017-03-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED COOLING THERAPY |
| Manufacturer Address | CHICAGO IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-03 |