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

Model Number BSM-6301A

Device Problems Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

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

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

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.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).

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

Details of complaint: the biomedical engineer (bme) reported they found that the spo2 alarms on some of the bedside monitors (bsm-6000 series) could be turned off, or they were able to turn the alarm's lower limit all the way down to 0.They wanted to adjust the settings to only allow the lower spo2 limit to be set to 90 as its lowest point.They stated there was an incident that day where someone had turned the lower spo2 setting off, and the patient had de-saturated to down to 42.Nihon kohden (nk) clinical explained to the bme how the alarm caps work and how to adjust the parameter limits.No patient harm or injury was reported.Investigation summary: this issue has a risk that may require medical or surgical intervention to prevent permanent injury or impairment to patient or user.No alarm sound has a risk of delay in treatment and of understanding the patient's condition.Should an event be missed due no alarm sounding, a patient death or serious injury is likely to occur.As the alarm settings were configured by the user, the device would not alarm unless the parameters fell out of the range set by the user.The user configured the settings to have no lower limit which resulted in no alarm sounding.There is no evidence of an nk device malfunction.The root cause is determined to use error.Nk technical support educated the user in a feature that limits how low a user can set alarm limits to avoid this issue from recurring.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported they found that the spo2 alarms on some of the bedside monitors (bsm-6000 series) could be turned off, or they were able to turn the alarm's lower limits down to 0.They stated there was an incident that day where someone had turned the lower spo2 setting off, and the patient had desatted to down to 42.

• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12457490
• MDR Text Key: 281682927
• Report Number: 8030229-2021-01680
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• 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: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2020
• 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: CNS-6801A SN (B)(6).; CNS-6801A SN (B)(6).