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

Model Number BSM-6301A

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/11/2021

Event Type  malfunction  

Event Description

The biomedical engineer that they found some bedside monitors (bsm-6000 series bedside monitors) where the spo2 alarms can be turned off, or they can turn it all the way down to 0.They want to adjust and lower the spo2 limit to be at 90 as the lowest point.They stated there was an incident this morning where someone turned the lower spo2 off, and the patient had desatted to 42.Nk clinical explained the alarm caps and where to turn it on and how to adjust the parameter limit.Mdr for user error and not device failure.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer that they found some bedside monitors (bsm-6000 series bedside monitors) where the spo2 alarms can be turned off, or they can turn it all the way down to 0.They want to adjust and lower the spo2 limit to be at 90 as the lowest point.They stated there was an incident this morning where someone turned the lower spo2 off, and the patient had desatted to 42.Nk clinical explained the alarm caps and where to turn it on and how to adjust the parameter limit.Mdr for user error and not device failure.No patient harm was reported.Additional device information: concomitant medical device: the following device(s) were being used in conjunction with the bsm.Central nurse's station: model: cns-6801a, sn: (b)(4).

• 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
• MDR Report Key: 12457505
• MDR Text Key: 281593194
• Report Number: 2080783-2021-01680
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: 04931921103517
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 09/10/2021

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2021
• Distributor Facility Aware Date: 08/11/2021
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CNS-6801A SN (B)(4)