FDA Adverse Event
Malfunction
Summary report: N
ASTRAL 150 - DEU
MDR report key: 4863531
·
Received June 19, 2015
Report
- Report Number
- 3004604967-2015-00216
- Event Type
- Malfunction
- Date Received
- June 19, 2015
- Manufacturer
- RESMED LTD.
- Product Code
- NOU
- PMA / PMN Number
- K133868
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES IN (B)(4) AND AN EVAL WAS PERFORMED. A REVIEW OF THE DOWNLOADED DEVICE EVENTS LOG CONFIRMED THAT A SINGLE OCCURRENCE OF A RESTART FROM A HIGH PRESSURE ALARM WAS TRIGGERED IN THE DEVICE. VISUAL INSPECTION OF THE DEVICE FOUND AN UNK FOREIGN SUBSTANCE, MOST LIKELY DRUG RESIDUE, IN THE HOSE AND FLOW SENSORS. THE DEVICE WAS CLEANED, SERVICED, CALIBRATED AND TESTED THEN RETURNED TO THE CUSTOMER. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT. (B)(4).
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399673 | ASTRAL 150 - DEU | VENTILATOR, CONTINUOUS (FACILITY/HOME) | NOU | RESMED LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |