PU-681RA
Report
- Report Number
- 8030229-2023-03751
- Event Type
- Malfunction
- Date Received
- September 12, 2023
- Date of Event
- August 13, 2023
- Report Date
- July 26, 2024
- Manufacturer
- NIHON KOHDEN CORPORATION
- Product Code
- MHX
- 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
DETAILS OF THE COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) STOPPED WORKING. THEY TRIED REBOOTING THE UNIT, BUT IT WILL NOT BOOT INTO THE BIOS OR WINDOWS. IT JUST DISPLAYS THE B4 ERROR ON THE CNS. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: MULTIPLE FOLLOW-UP REQUESTS WERE SENT TO THE CUSTOMER REGARDING THE RETURN OF THE DEVICE BUT THEY WERE UNRESPONSIVE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE WE HAVE NOT RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. POSSIBLE CAUSE OF THE SPONTANEOUS SHUTDOWN AND STARTUP FAILURE IS LIKELY RELATED TO HARDWARE COMPONENT FAILURE. HARDWARE COMPONENT FAILURE CAN OCCUR THROUGH PHYSICAL DAMAGE OR FLUID INTRUSION FROM USER MISHANDLING, POWER ISSUES FROM OUTAGES OR SURGES WHICH CAN AFFECT THE INTEGRITY OF ELECTRONIC COMPONENTS, OR WEAR-AND-TEAR WHICH DEPENDS ON DEVICE AGE AND FREQUENCY OF USE. REVIEW OF THE COMPLAINT DEVICE'S SERIAL NUMBER SHOWS THAT THE DEVICE IS 2 YEARS OLD AND SHOWS A PREVIOUS OCCURRENCE UNDER TICKET 176301 WHERE IT WAS REPORTED THAT THE UNIT WOULD NOT BOOT PAST BIOS. UNDER TICKET 176301 THE CUSTOMER WAS ORIGINALLY GOING TO SEND THE DEVICE IN FOR REPAIR SERVICE BUT LATER DECIDED NOT TO SINCE THEY WERE ABLE TO BOOT IT UP AGAIN, HOWEVER, THE ISSUE RECURRED UNDER THIS CURRENT TICKET 182481. REVIEW OF THE CUSTOMER'S COMPLAINT HISTORY FROM THE PAST 2 YEARS FOR CNS DEVICES SHOWS 6 SIMILAR COMPLAINTS UNDER TICKETS 98428, 103151, 144876, 151130, 151710, AND 163983. FOR TICKETS 98428, 144876, 151130, 151710, 163983, THE ISSUES WERE FOUND TO BE DUE TO HARD DRIVE CORRUPTION/FAILURE AND RESOLVED THROUGH HDD RE-IMAGING AND REPLACEMENT. A CAUSE WAS NOT DETERMINED FOR TICKET 103151 AS THE CUSTOMER WAS UNRESPONSIVE. THE CNS OPERATOR'S MANUAL RECOMMENDS PERIODIC REPLACEMENT OF THE HDD EVERY 2 YEARS. POSSIBLE HARDWARE COMPONENT FAILURE SUCH AS HDD CORRUPTION/FAILURE MAY BE RELATED TO LACK OF MAINTENANCE. THE FOLLOWING FIELDS ARE NOT APPLICABLE (NA) TO THE MDR REPORT: THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT THE INFORMATION WAS NOT PROVIDED. A2 - A6 B6 - B7 D10 CONCOMITANT MEDICAL DEVICE ATTEMPT #1 08/24/2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 08/31/2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #3 09/12/2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED.
CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME 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. D4 ADDITIONAL DEVICE INFORMATION / MODEL #: CORRECTED THE MODEL # FROM CNS-6801A TO PU-681RA. 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, PER THE FDA REQUEST.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) STOPPED WORKING. THEY TRIED REBOOTING THE UNIT, BUT IT WILL NOT BOOT INTO THE BIOS OR WINDOWS. IT JUST DISPLAYS THE B4 ERROR ON THE CNS. NO PATIENT HARM WAS 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. THE FOLLOWING FIELDS ARE NOT APPLICABLE (NA) TO THE MDR REPORT: B2 D4 LOT NUMBER & EXPIRATION D6A - D6B D7B F1 - F14 G4 DEVICE BLA NUMBER G5 G7 H2 H7 H9 THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT THE INFORMATION WAS NOT PROVIDED. A2 - A6 B6 - B7 D10 CONCOMITANT MEDICAL DEVICE ATTEMPT #1 (B)(6) 2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 (B)(6) 2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #3 (B)(6) 2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) STOPPED WORKING. THEY TRIED REBOOTING THE UNIT, BUT IT WILL NOT BOOT INTO THE BIOS OR WINDOWS. IT JUST DISPLAYS THE B4 ERROR ON THE CNS. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) STOPPED WORKING. THEY TRIED REBOOTING THE UNIT, BUT IT WILL NOT BOOT INTO THE BIOS OR WINDOWS. IT JUST DISPLAYS THE B4 ERROR ON THE CNS. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) STOPPED WORKING. THEY TRIED REBOOTING THE UNIT, BUT IT WILL NOT BOOT INTO THE BIOS OR WINDOWS. IT JUST DISPLAYS THE B4 ERROR ON THE CNS. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1104705 | PU-681RA | CENTRAL MONITOR SYSTEM (CNS-6801A) | MHX | NIHON KOHDEN CORPORATION | PU-681RA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |