FDA Adverse Event
Malfunction
Summary report: N
ASTRAL 150 - APAC
MDR report key: 6103262
·
Received November 15, 2016
Report
- Report Number
- 3004604967-2016-01230
- Event Type
- Malfunction
- Date Received
- November 15, 2016
- Report Date
- November 11, 2016
- Manufacturer
- RESMED LTD
- Product Code
- NOU
- PMA / PMN Number
- K133868
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED 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 |
|---|---|---|---|---|---|---|---|
| 754374 | ASTRAL 150 - APAC | NOU | RESMED LTD | 27083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |