MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6501A; VITAL SIGNS MONITOR

Model Number BSM-6501A

Device Problems No Device Output (1435); Unable to Obtain Readings (1516); Output Problem (3005)

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

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the bedside monitor (bsm) was not providing any spo2 readings.They did not know if there was an error message to alert the user of the failure when the spo2 failed or if they could not get the spo2 to work from the beginning.No patient harm was reported.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 biomedical engineer (bme) reported that the bedside monitor (bsm) was not providing any spo2 readings.They did not know if there was an error message to alert the user of the failure when the spo2 failed or if they could not get the spo2 to work from the beginning.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) was not providing spo2 readings.It was not clear if there was an error message to alert the user of the failure, and if they could not get the spo2 to work from the start.No patient harm or injury was reported.Investigation summary: they did not know if there was an error message when the spo2 failed or if they could not get the spo2 to work from the beginning.The customer later reported in a follow-up on (b)(6) 2023 that they swapped the input module from an unused room and the spo2 was fully functional after that.A definitive root cause could not be determined since the issue was resolved through routine troubleshooting and the complaint device would not be returned.Since the issue resolved after replacing the input unit, possible causes may include a loose connection between the input unit and main unit, issues with the spo2 cable connected to the original input unit, or a hardware component issue with the input unit.Cable and hardware component issues can include incompatibility between the spo2 cable and specific input unit, or component failure which can occur due to physical damage or fluid intrusion from user mishandling, electrical damage from outages or surges, or wear-and-tear which depends on device age and frequency of use.A review of the complaint device's serial number does not show a recurrence or other similar complaints.A review of the customer's complaint history does not show a recurrence or other similar complaints for this issue and device.A review of the customer's complaint history did not show any trends for this issue and device.Nk will continue to monitor and trend similar complaints.The following fields contains no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6 b6 - b7 d10 attempt #1 10/04/2023 emailed customer via microsoft outlook for all items in the no information section.No reply was received.Attempt #2 10/06/2023 emailed customer via microsoft outlook for all items in the no information section.The customer responded with complaint details, but did not provide the requested information.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 that the bedside monitor (bsm) was not providing spo2 readings.It was not clear if there was an error message to alert the user of the failure, and if they could not get the spo2 to work from the start.No patient harm was reported.

• Brand Name: BSM-6501A
• 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: 18008163
• MDR Text Key: 326562994
• Report Number: 8030229-2023-03849
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921103548
• UDI-Public: 04931921103548
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BSM-6501A
• Device Catalogue Number: MU-651RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2017
• 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