MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-02 for ESCAPE -RESMED- manufactured by .
[897788]
Patient was on a trip to multiple countries during 2008. Became ill and was hospitalized. Culture positive for legionella. Private physician told pt that illness probably related to hotel or restaurant not cpap. It is unclear if this was to keep patient compliant with cpap use. Patient used tap water in humidifier portion of cpap instead of distilled water. Cpap machine use is escape. Dose or amount: positive air pressure, frequency: nightly, route: nasal. Diagnosis or reason for use: obstructive sleep apena.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5007492 |
| MDR Report Key | 1068315 |
| Date Received | 2008-07-02 |
| Date of Report | 2008-07-01 |
| Date of Event | 2008-05-13 |
| Date Added to Maude | 2008-07-10 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESCAPE -RESMED- |
| Generic Name | CPAP MACHINE |
| Product Code | NHJ |
| Date Received | 2008-07-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1037306 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-02 |