MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6300A; VITAL SIGNS MONITOR

Model Number BSM-6300A

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Stops Intermittently (1599); Device Inoperable (1663); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that when they attempt to do a patient transfer, or print, the bsm (bedside monitor) reboots itself and all the patient data is gone.Nihon kohden technical support providing troubleshooting tips, including checking the ip address and recommending swapping the ports and rebooting the switch for this bsm.This resolved the issue.No harm was reported.

Event Description

The biomedical engineer reported that when they attempt to do a patient transfer, or print, the bsm reboots itself and all the patient data is gone.

Manufacturer Narrative

H10: additional narrative: on (b)(6) 2018, bme (b)(6) at (b)(6) affairs reported the bsm-6300a (mu-631ra sn: (b)(6) screen flashed and all patient data was gone.This occurred when they tried to do a patient transfer.Customer said this has happened in the past but he was not able to investigate it because by the time he got to the monitor, it was working again.Video of the incident was provided.Nka ts reviewed the provided video and suspected a duplicate ip or bad ip address was causing the issue.Bsm ip settings were verified to be correct.Customer said it will print fine intermittently but other times throw up the error, force reboot, and patient data is gone.This happened to another bsm in the same department.Customer was also having "comm loss" issues in the same department.Service requested: troubleshooting/assistance.Service performed: nka ts advised the customer to switch the ports on the switch for the bsm.Customer to do so and monitor the issue.Follow up was sent to the customer to determine if the issue was resolved, to which customer responded: i hope so.It's been almost a year ago.Investigation result: the bsm warranty began 10/29/2017, which is approximately 5 months prior to the reported issue.Review of device sap history found no previously reported issues with the unit.The unit was not returned and no nka evaluation was performed.Condition of the unit is unknown.Issue was not isolated to the unit as customer reported issue occurred with another bsm in the same department.Possible cause may be networking issues affecting multiple devices in the department.There was a suspected networking issue caused by the network switch.Customer was advised to perform further troubleshooting with the switch.After this point, it is unclear if the customer performed this or how the issue was resolved.Per customer response to follow up, customer did not appear to be aware of any continuing issues.Further information is not available.Per nkc dhr, the unit has had no history of ncmr, deviation, or capa during manufacturing of the device.The device has not been refurbished and there were no discrepancies or unusual findings before device release that might relate to the reported issue.There appears to be a trend of networking related issues at the customer's facility around the time of reported issue.This seemed to decrease after replacement of switch in (4).Based on the given information, the root cause cannot be confirmed.Potential cause is failure of the network switch.This issue is not suspected to be caused by deficiency of the bsm or its design.Corrected information: g4.Date received by manufacturer: should be 04/16/2018 not 05/15/2018 as listed on mdr initial report.Additional information: b4.Date of this report.F6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? additional information.Correction.H3.Device evaluated by manufacturer? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

Event Description

The biomedical engineer reported that when they attempt to do a patient transfer, or print, the bsm reboots itself and all the patient data is gone.

• Brand Name: BSM-6300A
• Type of Device: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7515639
• MDR Text Key: 108365939
• Report Number: 8030229-2018-00153
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: 04931921103517
• Combination Product (y/n): N
• PMA/PMN Number: K080342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BSM-6300A
• Device Catalogue Number: MU-631RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2019
• Distributor Facility Aware Date: 08/09/2019
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2019
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1