MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-1753A; VITAL SIGNS MONITOR

Model Number BSM-1753A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Patient Problem/Medical Problem (2688)

Event Date 01/17/2020

Event Type  Death  

Manufacturer Narrative

The customer reported that the bedside monitor (bsm) was hooked up to a patient in the er who had expired; when the unit was checked and still hooked up to the patient, after the death, the error message displayed was "disk status capacity is at 29%." nihon kohden technical support (nk ts) asked the customer to re-boot the unit.Afterwards, the message cleared, and the unit began to function normally.The customer would not give a firm answer on whether or not the death was caused by the bsm.The customer stated that she would speak with the nurse who was present in order to gather more information.Nk ts asked the customer to call back.On (b)(6) 2020 the customer emailed nk ts that she could now say with certainty that the device did not cause the patient death.She stated that she was still concerned about the error message and asked for the part number to replace the sim card.Nk ts asked the customer to return the mandatory adverse event form, but the customer did not respond.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.

Event Description

The customer reported that this bedside monitor (bsm) was hooked up to a patient in the er who had expired; when the unit was checked and still hooked up to the patient after the death, the error message displayed was "disk status capacity is at 29%.".

Event Description

The customer reported that this bedside monitor (bsm) was hooked up to a patient in the er who had expired; when the unit was checked and still hooked up to the patient after the death, the error message displayed was "disk status capacity is at 29%.".

Manufacturer Narrative

Details of complaint: on (b)(6) 2020, customer at sierra view medical center reported the error message, "disk status capacity is at 29%" while monitoring a patient in er who expired.The unit was monitoring the patient at the time of death; however, the customer would not provide clear information on whether or not the death of the patient was caused due to the bsm-1753a, serial # (b)(6).Service requested: assistance in troubleshooting the "disk status capacity is 29%" error message.Service performed: nk ts rebooted the unit to resolve the issue.Nk ts followed up with the customer to gather more information on the reported incident of the patient's death.Customer was unwilling to disclose more related information, after multiple follow ups.Root cause of the issue cannot be identified due to lack of information.Investigation summary: root cause of the issue could not be identified; however patient expired while being monitored on the bsm.Customer was not willing to disclose more information.Since, there is no further information related to the device malfunctioning, the complaint was reported to err on the side of caution.Warranty of the device is valid till 04/28/2023.According to the table in quality complaint investigations work instruction, document id: sop07-018, the severity of the "disk status capacity running low" error is low.However, the customer stated the unit was hooked up to the patient when the unit began displaying the error, and that the patient had expired.Therefore, the risk priority of this issue will be categorized as: high.If additional information is shared by the customer, the file will be reopened for complaint investigation.

• Brand Name: BSM-1753A
• 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: 9690766
• MDR Text Key: 178562303
• Report Number: 8030229-2020-00075
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921111871
• UDI-Public: 4931921111871
• Combination Product (y/n): N
• PMA/PMN Number: K080342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BSM-1753A
• Device Catalogue Number: BSM-1753A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2020
• Distributor Facility Aware Date: 04/28/2020
• Device Age: 32 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2020
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death