GALAXY SYSTEM
Report
- Report Number
- 3021325287-2025-00010
- Event Type
- Malfunction
- Date Received
- February 20, 2025
- Date of Event
- January 24, 2025
- Report Date
- April 17, 2025
- Manufacturer
- NOAH MEDICAL CORP.
- Product Code
- EOQ
- UDI-DI
- 00850048825048
- PMA / PMN Number
- K223144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
SYSTEM MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ISSUES ASSOCIATED WITH THIS CASE. SCOPE MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ISSUES ASSOCIATED WITH THIS CASE. PRELIMINARY INVESTIGATIONS REVEALED THAT THE BEHAVIOR OF THE E-STOP LED REMAINING ILLUMINATED AFTER AC POWER IS REMOVED FROM THE SYSTEM INPUT INDICATES THAT THE UPS IS CONTINUING TO POWER ITS AC OUTPUTS FROM ITS BATTERY. THE POTENTIAL IMPACT ON SUBSEQUENT CASES AFTER DELAYED SHUT DOWN WILL RESULT IN THE UPS NOT CHARGING SUFFICIENTLY TO SUPPORT THE FOLLOWING CASES IN THE EVENT OF A POWER FAILURE. NO OTHER MALFUNCTIONS WERE REPORTED. THIS MALFUNCTION IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: DURING A GALAXY-ASSISTED BIOPSY PROCEDURE, THE USER EXPERIENCED THE SYSTEM NOT BEING ABLE TO SHUT DOWN. INVESTIGATION FINDINGS REVEALED THAT THIS FAILURE INCREASED THE PROBABILITY OF A SEVERE INJURY FROM A FREQUENCY FROM 2 (REMOTE) - 4 (PROBABLE). NO INJURIES OR TREATMENT WERE REPORTED IN THIS CASE. UPDATE H11: INITIAL PRELIMINARY INVESTIGATION FINDINGS SUGGEST THAT THE MALFUNCTION OF THE UPS MAY INCREASE THE LIKELIHOOD OF SEVERE INJURY (BLEEDING, MAJOR) FROM A FREQUENCY OF 2 (REMOTE) TO 4 (PROBABLE). HOWEVER, FOLLOWING A FURTHER RISK ASSESSMENT REVIEW, IT HAS BEEN DETERMINED THAT THE MOST LIKELY RISK ASSOCIATED WITH UPS ISSUES IS AN ABORTED PROCEDURE, WITH A PROBABILITY OF 3 (OCCASIONAL). WHILE THE SEVERITY OF THE INITIAL RISK OF BLEEDING, MAJOR REMAINS AT 3 (SERIOUS), THE PROBABILITY HAS BEEN REASSESSED TO 1 (IMPROBABLE). THEREFORE, THE COMPLAINT IS DEEMED NON-REPORTABLE.
SYSTEM MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ISSUES ASSOCIATED WITH THIS CASE. SCOPE MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ISSUES ASSOCIATED WITH THIS CASE. PRELIMINARY INVESTIGATIONS REVEALED THAT THE BEHAVIOR OF THE E-STOP LED REMAINING ILLUMINATED AFTER AC POWER IS REMOVED FROM THE SYSTEM INPUT INDICATES THAT THE UPS IS CONTINUING TO POWER ITS AC OUTPUTS FROM ITS BATTERY. THE POTENTIAL IMPACT ON SUBSEQUENT CASES AFTER DELAYED SHUT DOWN WILL RESULT IN THE UPS NOT CHARGING SUFFICIENTLY TO SUPPORT THE FOLLOWING CASES IN THE EVENT OF A POWER FAILURE. NO OTHER MALFUNCTIONS WERE REPORTED. THIS MALFUNCTION IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: DURING A GALAXY-ASSISTED BIOPSY PROCEDURE, THE USER EXPERIENCED THE SYSTEM NOT BEING ABLE TO SHUT DOWN. INVESTIGATION FINDINGS REVEALED THAT THIS FAILURE INCREASED THE PROBABILITY OF A SEVERE INJURY FROM A FREQUENCY FROM 2 (REMOTE) - 4 (PROBABLE). NO INJURIES OR TREATMENT WERE REPORTED IN THIS CASE.
IT WAS REPORTED THAT AFTER A GALAXY-ASSISTED BIOPSY PROCEDURE, THE GALAXY SYSTEM DID NOT FULLY SHUT DOWN. THE SYSTEM WAS ABLE TO SHUT DOWN AFTER 15 MINUTES. THERE WERE NO INJURIES REPORTED OR TREATMENT ADMINISTERED WITH THIS CASE. NO OTHER MALFUNCTIONS WERE REPORTED.ALTHOUGH THERE WERE NO INJURIES REPORTED, THIS MALFUNCTION MAY CONTRIBUTE TO A SERIOUS INJURY.
IT WAS REPORTED THAT AFTER A GALAXY-ASSISTED BIOPSY PROCEDURE, THE GALAXY SYSTEM DID NOT FULLY SHUT DOWN. THE SYSTEM WAS ABLE TO SHUT DOWN AFTER 15 MINUTES. THERE WERE NO INJURIES REPORTED OR TREATMENT ADMINISTERED WITH THIS CASE. NO OTHER MALFUNCTIONS WERE REPORTED. ALTHOUGH THERE WERE NO INJURIES REPORTED, THIS MALFUNCTION MAY CONTRIBUTE TO A SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1472373 | GALAXY SYSTEM | GALAXY SYSTEM | EOQ | NOAH MEDICAL CORP. | 00850048825048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male |