NIHON KOHDEN LIFE SCOPE G7 BEDSIDE MONITORING SYSTEM
Report
- Report Number
- 8030229-2023-03948
- Event Type
- Malfunction
- Date Received
- December 20, 2023
- Date of Event
- November 28, 2023
- Report Date
- August 14, 2024
- Manufacturer
- NIHON KOHDEN CORPORATION
- Product Code
- MHX
- UDI-DI
- 04931921004517
- PMA / PMN Number
- K203435
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
COMPLAINT SUMMARY: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G7 MONITOR WAS STUCK IN A BLANK BLACK SCREEN WHILE MONITORING PATIENTS. WHEN THE BME EVALUATED THE UNIT, IT WAS ON AND IN THE MONITORING MODE, WHEN THE BME WENT TO POWER CYCLE IT OFF, THE UNIT WOULD NOT POWER BACK ON. THE BME UNPLUGGED THE POWER CABLE THEN PLUGGED IT BACK IN AND BROUGHT IT BACK UP, IT WAS STUCK ON THE POWER OFF SCREEN (THE POP UP WITH THE POWER BUTTONS). THE BME WILL SEND THE UNIT IN FOR EVALUATION AND REPAIR. THERE WAS NO HARM REPORTED. INVESTIGATION SUMMARY/ROOT CAUSE: NIHON KOHDEN REPAIR CENTER RECEIVED THE DEVICE WHICH WAS PUT THROUGH EXTENSIVE TESTING AND THE REPORTED PROBLEM OF "POWER ISSUE" WAS NOT DUPLICATED, DEVICE POWERED ON AS IT SHOULD AND WAS TESTED FOR 96 HOURS WITH NO ERRORS. REVIEW OF THE COMPLAINT DEVICE'S SERIAL NUMBER (SN 494) SHOWS 1 PREVIOUS OCCURRENCE UNDER TICKET 191451 BUT WE COULD NOT DUPLICATE THE COMPLAINT DURING THE PREVIOUS EVALUATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE WE COULD NOT DUPLICATE THE COMPLAINT DURING EVALUATION. POSSIBLE CAUSES MAY BE RELATED TO USER ERROR WITH DEVICE SET-UP OR AN ISSUE WITH THE POWER SOURCE AT THE CUSTOMER SITE. NK WILL CONTINUE TO MONITOR AND TREND SIMILAR COMPLAINTS. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A2 - A6 B6 B7 D10 ATTEMPT # 1: 11/30/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE NO INFORMATION FIELDS ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 12/12/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE NO INFORMATION FIELDS ABOVE: REPLY WAS RECEIVED FROM THE BIOMEDICAL ENGINEER WHO STATED THAT HE IS NOT AT LIBERTY TO PROVIDE THE REQUESTED INFORMATION. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW-UP, WHAT TYPE? H3 DEVICE EVALUATED BY MANUFACTURER? H6 EVENT PROBLEM AND EVALUATION CODES H10 ADDITIONAL MANUFACTURER NARRATIVE.
UDI RELATED DATA QUALITY UPDATES. CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME FROM CSM-1702 TO NIHON KOHDEN LIFE SCOPE G7 BEDSIDE MONITORING SYSTEM. D4 ADDITIONAL DEVICE INFORMATION / MODEL #: CORRECTED THE MODEL # FROM CSM-1702 TO CU-172R. D4 ADDITIONAL DEVICE INFORMATION / CATALOG #: CORRECTED THE CATALOG # FROM CSM-1702 TO CU-172R. 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. ADDITIONAL INFORMATION: B4 DATA OF THIS REPORT G6 TYPE OF REPORT H2 IF FOLLOW UP, WHAT TYPE?
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G7 MONITOR WAS STUCK IN A BLANK BLACK SCREEN WHILE MONITORING PATIENTS. WHEN THE BME EVALUATED THE UNIT, IT WAS ON AND IN THE MONITORING MODE, WHEN THE BME WENT TO POWER CYCLE IT OFF, THE UNIT WOULD NOT POWER BACK ON. THE BME UNPLUGGED THE POWER CABLE THEN PLUGGED IT BACK IN AND BROUGHT IT BACK UP, IT WAS STUCK ON THE POWER OFF SCREEN (THE POP UP WITH THE POWER BUTTONS). THE BME WILL SEND THE UNIT IN FOR EVALUATION AND REPAIR. THERE WAS NO HARM 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 BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G7 MONITOR WAS STUCK IN A BLANK BLACK SCREEN WHILE MONITORING PATIENTS. WHEN THE BME TESTED THE UNIT, IT WAS ON AND IN THE MONITORING MODE, WHEN THE BME WENT TO POWER CYCLE IT OFF, THE UNIT WOULD NOT POWER BACK ON. THE BME UNPLUGGED THE POWER CABLE THEN PLUGGED IT BACK IN AND BROUGHT IT BACK UP, IT WAS STUCK ON THE POWER OFF SCREEN (THE POP UP WITH THE POWER BUTTONS). THE BME WILL SEND THE UNIT IN FOR EVALUATION AND REPAIR. THERE WAS NO HARM REPORTED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G7 MONITOR WAS STUCK IN A BLANK BLACK SCREEN WHILE MONITORING PATIENTS. WHEN THE BME TESTED THE UNIT, IT WAS ON AND IN THE MONITORING MODE, WHEN THE BME WENT TO POWER CYCLE IT OFF, THE UNIT WOULD NOT POWER BACK ON. THE BME UNPLUGGED THE POWER CABLE THEN PLUGGED IT BACK IN AND BROUGHT IT BACK UP, IT WAS STUCK ON THE POWER OFF SCREEN (THE POP UP WITH THE POWER BUTTONS). THE BME WILL SEND THE UNIT IN FOR EVALUATION AND REPAIR. THERE WAS NO HARM REPORTED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G7 MONITOR WAS STUCK IN A BLANK BLACK SCREEN WHILE MONITORING PATIENTS. WHEN THE BME TESTED THE UNIT, IT WAS ON AND IN THE MONITORING MODE, WHEN THE BME WENT TO POWER CYCLE IT OFF, THE UNIT WOULD NOT POWER BACK ON. THE BME UNPLUGGED THE POWER CABLE THEN PLUGGED IT BACK IN AND BROUGHT IT BACK UP, IT WAS STUCK ON THE POWER OFF SCREEN (THE POP UP WITH THE POWER BUTTONS). THE BME WILL SEND THE UNIT IN FOR EVALUATION AND REPAIR. THERE WAS NO HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2051709 | NIHON KOHDEN LIFE SCOPE G7 BEDSIDE MONITORING SYSTEM | VITAL SIGNS MONITOR CORE UNIT - G7 (CSM-1702) | MHX | NIHON KOHDEN CORPORATION | CU-172R | NA | 04931921004517 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NI.| NI.| NI. |