FDA Adverse Event
Malfunction
Summary report: N
ASTRAL 100 - AMER
MDR report key: 9579718
·
Received January 12, 2020
Report
- Report Number
- 3007573469-2020-00132
- Event Type
- Malfunction
- Date Received
- January 12, 2020
- Report Date
- January 12, 2020
- Manufacturer
- RESMED LTD
- Product Code
- CBK
- UDI-DI
- 00619498270019
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. 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 THAT AN ASTRAL DEVICE FAILED TO CHARGE ITS INTERNAL BATTERY. 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 |
|---|---|---|---|---|---|---|---|
| 42447 | ASTRAL 100 - AMER | CBK | RESMED LTD | 27001 | 00619498270019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |