FDA Adverse Event
Malfunction
Summary report: N
ASTRAL 150 - AMER
MDR report key: 6200724
·
Received December 22, 2016
Report
- Report Number
- 3004604967-2016-01405
- Event Type
- Malfunction
- Date Received
- December 22, 2016
- Report Date
- December 22, 2016
- Manufacturer
- RESMED LTD
- Product Code
- CBK
- PMA / PMN Number
- K133868
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A SOFTWARE ISSUE. THE DEVICE SOFTWARE WAS SERVICED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 849812 | ASTRAL 150 - AMER | CBK | RESMED LTD | 27003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |