MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6301A; VITAL SIGNS MONITOR

Model Number BSM-6301A

Device Problem Patient Data Problem (3197)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2023

Event Type  malfunction  

Event Description

The nurse reported that after a patient came back from a cat scan and was put back on to this unit, the patient was getting an invasive blood pressure (ibp) issue where it is saying "zeroing needed" over and over, when the nurse goes to zero though, the device says out of range.The nurse changed the transducer and redocked the input unit, but the issue still persisted.The nurse reports that she reseated the ibp cable with no improvement.Nihon kohden technical support recommended that the nurse also try a different input unit or try rebooting the bedside.The nurse dropped off the line while looking for another ibp cable and when nk technical support called her back they just got to the main switch board.Nihon kohden technician have sent emails to obtain more information and no response from the nurse have been received.

Manufacturer Narrative

Complaint details: the nurse reported that after a patient came back from a cat scan and was put back on to this unit, the patient was getting an invasive blood pressure (ibp) issue where it is saying "zeroing needed" over and over, when the nurse goes to zero though, the device says out of range.The nurse changed the transducer and redocked the input unit, but the issue still persisted.The nurse reports that she reseated the ibp cable with no improvement.Nihon kohden technical support recommended that the nurse also try a different input unit or try rebooting the bedside.The nurse dropped off the line while looking for another ibp cable and when nk technical support called her back they just got to the main switch board.Nihon kohden technician have sent emails to obtain more information and no response from the nurse have been received.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 contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 b7 d10.

Manufacturer Narrative

Complaint details: on (b)(6) 2023, the nurse reported that after a patient came back from a cat scan on the bedside monitor (mu-631ra, serial number (b)(6)) they were getting an ibp issue where the unit said, "zeroing" needed over and over.When the customer attempted to zero the unit, another error message would appear saying, "out of range." the customer changed the transducer and redocked the input unit, but the issue persisted.Nk technical support recommended trying a different input unit or rebooting the bedside.The customer was looking for another ibp cable when the call dropped.Nk technical support followed up with the customer and they stated restarting the monitor and changing the connection wire to the cvp transducer resolved the issue.There was patient involvement when the issue occurred, but no report of injury, no harm, nor any adverse event, due to the reported issue.Investigation summary: root cause analysis: we were unable to confirm the reported issue as the unit was not shipped in for evaluation.As such a definitive root cause cannot be determined.The bsm-6000 operators manual states if the nibp zeroing is being performed, the cuff must not be touched during the zeroing phase.Additionally, if the error message "zero out of range" is seen then the transducer needs to be replaced.User error could be a contributing factor while performing these functions.The cuff could have had movement, and the transducer may not have been facing open air as the operators manual suggests.Another potential cause could have been the cable that connects the transducer could have been defective.Once the cable was replaced and the device was rebooted the issue was resolved.Device history: a serial number review of the reported device (mu-631ra, serial number (b)(6)) does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.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: 10/18/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 11/03/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 11/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Additional information b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 adverse event codes h10 manufacturer narrative.

Event Description

The nurse reported that after a patient came back from a cat scan and was put back on to this unit, the patient was getting an invasive blood pressure (ibp) issue where it is saying "zeroing needed" over and over, when the nurse goes to zero though, the device says out of range.The nurse changed the transducer and redocked the input unit, but the issue still persisted.The nurse reports that she reseated the ibp cable with no improvement.Nihon kohden technical support recommended that the nurse also try a different input unit or try rebooting the bedside.The nurse dropped off the line while looking for another ibp cable and when nk technical support called her back they just got to the main switch board.Nihon kohden technician have sent emails to obtain more information and no response from the nurse have been received.

• Brand Name: BSM-6301A
• Type of Device: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18089187
• MDR Text Key: 328498959
• Report Number: 8030229-2023-03861
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: 04931921103517
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BSM-6301A
• Device Catalogue Number: MU-631RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1