FDA Adverse Event
Malfunction
Summary report: N
ASTRAL BATTERY PACK
MDR report key: 11153402
·
Received January 12, 2021
Report
- Report Number
- 3007573469-2021-00088
- Event Type
- Malfunction
- Date Received
- January 12, 2021
- Date of Event
- April 8, 2020
- Report Date
- January 12, 2021
- Manufacturer
- RESMED LTD
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
THE ASTRAL DEVICE WAS RETURNED TO RESMED FOR AN INVESTIGATION. REVIEW OF THE DEVICE DATA LOGS CONFIRMED THE REPORTED COMPLAINT AND REVEALED AN ERROR MESSAGE (SF180) RELATED TO A BATTERY CHARGER FAULT. BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT WAS DUE TO AN ISOLATED COMPONENT FAILURE WITHIN THE DEVICE BATTERY ASSEMBLY. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE#: PR 2003006.
Description of Event or Problem · 0
IT WAS REPORTED TO RESMED THAT AN ASTRAL BATTERY FAILED TESTING AND DISPLAYS THE INTERNAL BATTERY DEGRADED WARNING ALARM. 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 |
|---|---|---|---|---|---|---|---|
| 52093 | ASTRAL BATTERY PACK | CBK | RESMED LTD | 19620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |