FDA Adverse Event
Malfunction
Summary report: N
ASTRAL 150 - AMER
MDR report key: 9572316
·
Received January 9, 2020
Report
- Report Number
- 3007573469-2020-00041
- Event Type
- Malfunction
- Date Received
- January 9, 2020
- Report Date
- January 9, 2020
- Manufacturer
- RESMED LTD
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO RESMED FOR AN EVALUATION. A RESMED CUSTOMER REPRESENTATIVE ADVISED THE CUSTOMER TO PERFORM A HARD RESET OF THE DEVICE. RESMED REFERENCE #: (B)(4). REPORT LATE DUE TO TRANSITION FROM VMSR PROGRAM. ESTABLISHMENT WAS UNAWARE OF FDA LETTER DATED 16 SEPTEMBER 2019 FOR CBK PROCODE STATUS CHANGE IN VMSR PROGRAM UNTIL NOTIFIED DIRECTLY BY FDA ON 18 DECEMBER 2019 FOLLOWING SUBMISSION OF OUR QUARTERLY SUMMARY REPORT.
Description of Event or Problem · 1
IT WAS REPORTED TO RESMED AN ASTRAL DEVICE HAD AN UNRESPONSIVE TOUCHSCREEN. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 35727 | ASTRAL 150 - AMER | CBK | RESMED LTD | 27003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |