CNS-9700A
Report
- Report Number
- 8030229-2020-00198
- Event Type
- Malfunction
- Date Received
- April 2, 2020
- Date of Event
- March 10, 2020
- Report Date
- November 17, 2020
- Manufacturer
- NIHON KOHDEN CORPORATION
- Product Code
- MHX
- UDI-DI
- 04931921000663
- PMA / PMN Number
- K023475
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
DETAILS OF COMPLAINT: ON (B)(6) 2020, THE CUSTOMER AT LOVELACE HEALTH SYSTEM, INC. REPORTED THAT 3 BSM-2351A'S WERE IN COMM LOSS. HE SAID THAT HE PREVIOUSLY REBOOTED THEM. THESE UNITS HAVE WIRELESS CARDS. DETAILS OF DEVICE RELATED TO THE ISSUE HAVE NOT BEEN REPORTED AT THE TIME OF COMPLAINT, SUCH INCIDENTS ARE ADDRESSED UNDER CAPA-18-033. SERVICE REQUESTED: TROUBLESHOOTING. SERVICE PERFORMED: TROUBLESHOOTING. INVESTIGATION SUMMARY: AFTER MULTIPLE FOLLOW UPS BY NK, THE CUSTOMER CALLED BACK TO INFORM THAT THE ISSUE WAS RESOLVED BY RESTARTING THE BEDSIDES. THE REPORTED ISSUE OCCURS OCCASIONALLY AND RESTARTING THE UNIT RESOLVES THE ISSUE. IF THE CUSTOMER REACHES OUT WITH ADDITIONAL INFORMATION, THE FILE WILL BE REOPENED FOR QA COMPLAINT INVESTIGATION. ROOT CAUSE OF THE ISSUE COULD NOT BE IDENTIFIED AS THE CUSTOMER IS DECIDING WHETHER THEY WANT TO TROUBLESHOOT THE ISSUE OR REPLACE THE DEVICE. THE RISK PRIORITY OF THE ISSUE IS CATEGORIZED AS: LOW ADDITIONAL DEVICE INFORMATION: D11 & C2 CONCOMITANT MEDICAL DEVICE INFORMATION: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS: BEDSIDE MONITOR MODEL: BSM-2351A SN: NI BEDSIDE MONITOR MODEL: BSM-2351A SN: NI BEDSIDE MONITOR MODEL: BSM-2351A SN: NI
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS IN COMMUNICATION LOSS WITH 3 BEDSIDE MONITORS (BSM). THE CUSTOMER SAID THAT THEY PREVIOUSLY REBOOTED THEM. THESE UNITS HAVE WIRELESS CARDS. NIHON KOHDEN TECHNICAL SUPPORT HAD THEM REBOOT THE CNS AND THE 3 BSMS. ONCE THEY WERE ALL REBOOTED, THEY WERE COMMUNICATING AGAIN. NO PATIENT HARM REPORTED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS IN COMMUNICATION LOSS WITH 3 BEDSIDE MONITORS (BSM). THE CUSTOMER SAID THAT THEY PREVIOUSLY REBOOTED THEM. THESE UNITS HAVE WIRELESS CARDS. NIHON KOHDEN TECHNICAL SUPPORT HAD THEM REBOOT THE CNS AND THE 3 BSMS. ONCE THEY WERE ALL REBOOTED, THEY WERE COMMUNICATING AGAIN. NO PATIENT 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. AS THE SERIAL NUMBER WAS NOT PROVIDED FOR THE CNS, THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: DEVICE SERIAL NUMBER, AGE OF DEVICE, DEVICE MANUFACTURE DATE. CONCOMITANT MEDICAL DEVICE INFORMATION: BEDSIDE MONITOR: MODEL: BSM-2351A, SN: NI. BEDSIDE MONITOR: MODEL: BSM-2351A, SN: NI. BEDSIDE MONITOR: MODEL: BSM-2351A, SN: NI.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS IN COMMUNICATION LOSS WITH 3 BEDSIDE MONITORS (BSM). THE CUSTOMER SAID THAT THEY PREVIOUSLY REBOOTED THEM. THESE UNITS HAVE WIRELESS CARDS. NIHON KOHDEN TECHNICAL SUPPORT HAD THEM REBOOT THE CNS AND THE 3 BSMS. ONCE THEY WERE ALL REBOOTED, THEY WERE COMMUNICATING AGAIN. NO PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 379362 | CNS-9700A | CENTRAL MONITOR SYSTEM | MHX | NIHON KOHDEN CORPORATION | CNS-9700A | NA | 04931921000663 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | BSM-2351A NO SERIAL NUMBER| BSM-2351A NO SERIAL NUMBER| BSM-2351A NO SERIAL NUMBER| BSM-2351A NO SERIAL NUMBER| BSM-2351A NO SERIAL NUMBER| BSM-2351A NO SERIAL NUMBER |