PU-681RA
Report
- Report Number
- 8030229-2025-05258
- Event Type
- Malfunction
- Date Received
- August 12, 2025
- Date of Event
- July 22, 2025
- Report Date
- October 31, 2025
- Manufacturer
- NIHON KOHDEN CORPORATION
- Product Code
- MHX
- UDI-DI
- 04931921131640
- PMA / PMN Number
- K102376
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAVE BEEN GETTING BLUE SCREEN ERRORS, AND THE UNIT RESTARTS ITSELF WHICH STARTED ABOUT A WEEK AGO. TECH SUPPORT (TS) EXPLAINED THIS WOULD BE AN HDD FAILURE, BUT WE CAN DO HDD TROUBLESHOOTING TO DETERMINE IF ONLY ONE DRIVE IS BAD OR BOTH. TS EXPLAINED ALL THE STEPS TO PROPERLY TROUBLESHOOT THE HDDS. THE CUSTOMER HAS DONE THE HDD TROUBLESHOOTING, AND THE ISSUE PERSISTS REGARDLESS OF WHAT HDD HE USES. HE WOULD LIKE TO MOVE FORWARD WITH SENDING THE UNIT IN FOR A REPAIR AND GETTING REPLACEMENT DRIVES. NOT IN PATIENT USE. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAVE BEEN GETTING BLUE SCREEN ERRORS, AND THE UNIT RESTARTS ITSELF WHICH STARTED ABOUT A WEEK AGO. TECH SUPPORT (TS) EXPLAINED THIS WOULD BE AN HDD FAILURE, BUT WE CAN DO HDD TROUBLESHOOTING TO DETERMINE IF ONLY ONE DRIVE IS BAD OR BOTH. TS EXPLAINED ALL THE STEPS TO PROPERLY TROUBLESHOOT THE HDDS. THE CUSTOMER HAS DONE THE HDD TROUBLESHOOTING, AND THE ISSUE PERSISTS REGARDLESS OF WHAT HDD HE USES. HE WOULD LIKE TO MOVE FORWARD WITH SENDING THE UNIT IN FOR A REPAIR AND GETTING REPLACEMENT DRIVES. NOT IN PATIENT USE. INVESTIGATION CONCLUSION: THE CUSTOMER REPORTED RECURRING BLUE SCREEN ERRORS AND AUTOMATIC RESTARTS ON A CNS (PU-681RA). NK TECH SUPPORT COORDINATED A LOANER AND REPAIR. AT THE REPAIR CENTER, THE ISSUE WAS DUPLICATED. EVALUATION IDENTIFIED CORRUPTED SOFTWARE AND DEGRADED HARD DRIVES. BOTH HDDS WERE REPLACED AND RE-IMAGED, SYSTEM INITIALIZATION AND FUNCTIONAL CHECKS WERE COMPLETED, AND THE UNIT PASSED EXTENDED TESTING. ROOT CAUSE INVESTIGATION: THE ROOT CAUSE IS HARDWARE COMPONENT DEGRADATION OF THE HARD DRIVES WITH SOFTWARE CORRUPTION.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAVE BEEN GETTING BLUE SCREEN ERRORS, AND THE UNIT RESTARTS ITSELF WHICH STARTED ABOUT A WEEK AGO. TECH SUPPORT (TS) EXPLAINED THIS WOULD BE AN HDD FAILURE, BUT WE CAN DO HDD TROUBLESHOOTING TO DETERMINE IF ONLY ONE DRIVE IS BAD OR BOTH. TS EXPLAINED ALL THE STEPS TO PROPERLY TROUBLESHOOT THE HDDS. THE CUSTOMER HAS DONE THE HDD TROUBLESHOOTING, AND THE ISSUE PERSISTS REGARDLESS OF WHAT HDD HE USES. HE WOULD LIKE TO MOVE FORWARD WITH SENDING THE UNIT IN FOR A REPAIR AND GETTING REPLACEMENT DRIVES. NOT IN PATIENT USE.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAVE BEEN GETTING BLUE SCREEN ERRORS, AND THE UNIT RESTARTS ITSELF WHICH STARTED ABOUT A WEEK AGO. TECH SUPPORT (TS) EXPLAINED THIS WOULD BE AN HDD FAILURE, BUT WE CAN DO HDD TROUBLESHOOTING TO DETERMINE IF ONLY ONE DRIVE IS BAD OR BOTH. TS EXPLAINED ALL THE STEPS TO PROPERLY TROUBLESHOOT THE HDDS. THE CUSTOMER HAS DONE THE HDD TROUBLESHOOTING, AND THE ISSUE PERSISTS REGARDLESS OF WHAT HDD HE USES. HE WOULD LIKE TO MOVE FORWARD WITH SENDING THE UNIT IN FOR A REPAIR AND GETTING REPLACEMENT DRIVES. NOT IN PATIENT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2258788 | PU-681RA | CENTRAL MONITORING SYSTEM | MHX | NIHON KOHDEN CORPORATION | PU-681RA | NA | 04931921131640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |