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

Model Number BSM-6301A

Device Problems Loss of Power (1475); Power Problem (3010)

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

Event Date 08/09/2023

Event Type  malfunction  

Event Description

The nurse reported that the bedside shut off randomly while in-use and there was no led indicator showing a light on the front.The nurse said that they checked the power connection and confirmed it is plugged in correctly and re-seated it.The nurse also tried a second outlet but the issue persists.No patient harm was reported.Nihon kohden technician told the nurse to reach out to their biomedical engineer to continued troubleshooting the issue.No further information has been received.

Manufacturer Narrative

The nurse reported that the bedside shut off randomly while in-use and there was no led indicator showing a light on the front.The nurse said that they checked the power connection and confirmed it is plugged in correctly and re-seated it.The nurse also tried a second outlet but the issue persists.No patient harm was reported.Nihon kohden technician told the nurse to reach out to their biomedical engineer to continued troubleshooting the issue.No further information has 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.

Event Description

The nurse reported that the bedside shut off randomly while in-use and there was no led indicator showing a light on the front.The nurse said that they checked the power connection and confirmed it is plugged in correctly and re-seated it.The nurse also tried a second outlet but the issue persists.No patient harm was reported.Nihon kohden technician told the nurse to reach out to their biomedical engineer to continude troubleshooting the issue.No further information has been received.

Manufacturer Narrative

Complaint summary: the nurse reported that the bedside shut off randomly while in-use and there was no led indicator showing a light on the front.The nurse said that they checked the power connection and confirmed it is plugged in correctly and re-seated it.The nurse also tried a second outlet, ut the issue persists.No patient harm was reported.Nihon kohden technician told the nurse to reach out to their biomedical engineer to continue troubleshooting the issue.No further information has been received.Investigation summary: customers nurse reported that the bedside shut off randomly while in-use and there is no led indicator showing a light on the front.The nurse said that they checked the power connection and confirmed it is plugged in correctly and re-seated it.The nurse also tried a second outlet, but the issue persists.Nk technician asked the nurse to reach out to their biomed to try a different power cable or process an exchange/repair unit.Root cause investigation : multiple follow-up requests for additional information were sent to the customer but they were unresponsive.A definitive root cause could not be determined since we could not confirm resolution details or if the customer would return the complaint device for evaluation.Possible causes may include a faulty power cable or hardware component failure of the bsm.Power cables and hardware components may fail due to physical damage or fluid intrusion from user mishandling, power issues from outages or surges which can affect the integrity of electronic components, or wear-and-tear which depends on the device age and frequency of use.Review of the complaint device's serial number shows that the unit has been in service for 3 years and does not have other 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: 08/11/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 08/31/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 09/11/2023 emailed the customer via microsoft outlook for patient information: no reply was 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: 17726546
• MDR Text Key: 323787560
• Report Number: 8030229-2023-03754
• Device Sequence Number: 1
• Product Code: MHX
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• 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
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2020
• 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
• Treatment: NA.; NA.