PU-681RA
Report
- Report Number
- 8030229-2023-03802
- Event Type
- Malfunction
- Date Received
- October 10, 2023
- Date of Event
- September 11, 2023
- Report Date
- August 6, 2024
- 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
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE CUSTOMER REPORTED THAT ONE OF THEIR PATIENTS WAS HAVING A RANDOM V-FIB EPISODE AND THE CENTRAL NURSE'S STATION (CNS) DID NOT DISPLAY ANY V-FIB. THE CUSTOMER WANTED TO KNOW IF THERE WERE ANY SETTINGS THAT NEEDED TO BE CHANGED. TECHNICAL SUPPORT (TS) WALKED THE CUSTOMER THROUGH THE PROCESS OF CHECKING THE SETTING AND CONFIRMED THAT V-FIB WAS INDEED SELECTED. THE CUSTOMER ALSO CONFIRMED THAT THE ARRHYTHMIA ALARM FOR V-FIB WAS TURNED ON. TS HAD THE CUSTOMER REBOOT THE CNS; HOWEVER, THE ISSUE PERSISTED. TS IS WORKING WITH THE CUSTOMER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY REPORTED. 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.
UDI RELATED DATA QUALITY UPDATES. CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME FROM CNS-6801A TO PU-681RA. D4 ADDITIONAL DEVICE INFORMATION / MODEL #: CORRECTED THE MODEL # FROM CNS-6801A TO PU-681RA. D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PRODUCTION IDENTIFIER (PI) INFORMATION. THIS IS A CORRECTION TO THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A.
DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT ONE OF THEIR PATIENTS WAS HAVING V-FIB EPISODES, BUT THE CENTRAL NURSE'S STATION (CNS) WAS NOT DISPLAYING OR ALARMING FOR THE V-FIB EVENTS DESPITE HAVING SET THE CNS TO ALARM FOR THAT EVENT TYPE. REBOOTING THE CNS DID NOT RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: TECHNICAL SUPPORT (TS) WALKED THE CUSTOMER THROUGH THE PROCESS OF CHECKING THE SETTING AND CONFIRMED THAT V-FIB WAS INDEED SELECTED. THE CUSTOMER ALSO CONFIRMED THAT THE ARRHYTHMIA ALARM FOR V-FIB WAS TURNED ON. TS HAD THE CUSTOMER REBOOT THE CNS, WHICH DID NOT RESOLVE THE ISSUE. MULTIPLE FOLLOW-UP REQUESTS WERE SENT TO THE CUSTOMER, BUT THEY WERE UNRESPONSIVE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE WE COULD NOT CONFIRM FURTHER TROUBLESHOOTING OR RESOLUTION DETAILS. POSSIBLE CAUSES MAY INCLUDE USER ERROR WITH SET-UP, LACK OF MAINTENANCE, OR HARD DRIVE ISSUES. IF THE USER WAS REMOTELY VIEWING THE BEDSIDE DEVICE, ARRHYTHMIA RECALL DATA MAY NOT DISPLAY IF THE CNS THE BEDSIDE DEVICE WAS LOCALLY FILING DATA TO WAS NOT POWERED ON. PERIODIC MAINTENANCE OF THE CNS INCLUDES REBOOTING THE DEVICE EVERY 3 MONTHS TO PREVENT ISSUES WITH SLOW OPERATION AND LOADING SAVED DATA. HARD DRIVE ISSUES MAY ALSO AFFECT ARRHYTHMIA RECALL DATA SINCE THIS COMPONENT IS RESPONSIBLE FOR DATA STORAGE. HARD DRIVE ISSUES MAY OCCUR THROUGH PHYSICAL DAMAGE FROM USER MISHANDLING, ELECTRICAL DAMAGE FROM OUTAGES OR POWER SURGES, OR WEAR-AND-TEAR THAT DEPENDS ON DEVICE AGE AND FREQUENCY OF USE. THE CNS OPERATOR'S MANUAL ALSO RECOMMENDS REPLACING THE HARD DRIVES EVERY 2 YEARS. REVIEW OF THE COMPLAINT DEVICE'S SERIAL NUMBER SHOWS THAT THE UNIT IS 2 YEARS OLD AND DOES NOT HAVE OTHER SIMILAR COMPLAINTS. A REVIEW OF THE CUSTOMER'S COMPLAINT HISTORY DOES NOT SHOW OTHER SIMILAR COMPLAINTS. REVIEW OF THE CUSTOMER'S COMPLAINT HISTORY DID NOT SHOW ANY TRENDS FOR THIS ISSUE AND DEVICE. NK WILL CONTINUE TO MONITOR AND TREND SIMILAR COMPLAINTS.
THE CUSTOMER REPORTED THAT ONE OF THEIR PATIENTS WAS HAVING A RANDOM V-FIB EPISODE AND THE CENTRAL NURSE'S STATION (CNS) DID NOT DISPLAY ANY V-FIB. THERE WAS NO PATIENT INJURY REPORTED.
THE CUSTOMER REPORTED THAT ONE OF THEIR PATIENTS WAS HAVING V-FIB EPISODES, BUT THE CENTRAL NURSE'S STATION (CNS) WAS NOT DISPLAYING OR ALARMING FOR THE V-FIB EVENTS DESPITE HAVING SET THE CNS TO ALARM FOR THAT EVENT TYPE. REBOOTING THE CNS DID NOT RESOLVE THE ISSUE. NO PATIENT INJURY WAS REPORTED.
THE CUSTOMER REPORTED THAT ONE OF THEIR PATIENTS WAS HAVING V-FIB EPISODES, BUT THE CENTRAL NURSE'S STATION (CNS) WAS NOT DISPLAYING OR ALARMING FOR THE V-FIB EVENTS DESPITE HAVING SET THE CNS TO ALARM FOR THAT EVENT TYPE. REBOOTING THE CNS DID NOT RESOLVE THE ISSUE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1179776 | PU-681RA | CENTRAL MONITOR SYSTEM (CNS-6801A) | MHX | NIHON KOHDEN CORPORATION | PU-681RA | NA | 04931921131640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |