FDA Adverse Event
Malfunction
Summary report: N
ASTRAL PSU SLIM LINE
MDR report key: 9572343
·
Received January 9, 2020
Report
- Report Number
- 3004604967-2020-00044
- Event Type
- Malfunction
- Date Received
- January 9, 2020
- Report Date
- January 9, 2020
- Manufacturer
- RESMED LTD
- Product Code
- CBK
- PMA / PMN Number
- K152068
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO AN AUTHORIZED RESMED THIRD PARTY SERVICE CENTER FOR AN EVALUATION AND SERVICE. THE CUSTOMER WAS ISSUED WITH A REPLACEMENT POWER SUPPLY UNIT AS PART OF A WARRANTY CLAIM. (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 POWER SUPPLY UNIT (PSU) WAS INOPERABLE. 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 |
|---|---|---|---|---|---|---|---|
| 36118 | ASTRAL PSU SLIM LINE | CBK | RESMED LTD | 27966 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |