MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-2304A; VITAL SIGNS MONITOR

Model Number BSM-2304A

Device Problems Overheating of Device (1437); Application Program Problem (2880); Temperature Problem (3022)

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

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that they were taking the vitals from a patient when they noticed the unit started to have smoke coming from it, they immediately unplugged the monitor.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 reported that they were taking the vitals from a patient when they noticed the unit started to have smoke coming from it, they immediately unplugged the monitor.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer reported that they were taking the vitals of a patient when they noticed the bedside monitor (bsm) start smoking.They immediately unplugged the monitor.No patient harm or injury was reported.Investigation summary: the customer suspected that the cleaning residue may have caused the issue.They returned the complaint unit for repair.During the evaluation, the complaint unit was no longer powering on.It was identified that the customer was using a third-party battery.A review of the history of the serial number identified no other occurrences of this issue.Based on the available information, a definitive root cause could not be identified.However, it is likely that the third-party battery is not compatible with the device and may have caused the device to smoke.The cause of the issue is likely due to the use of a third-party battery.

Event Description

The biomedical engineer reported that they were taking the vitals from a patient when they noticed the unit started to have smoke coming from it, they immediately unplugged the monitor.No patient harm was reported.

• Brand Name: BSM-2304A
• 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 37023 14; JA 3702314
• 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: 11290530
• MDR Text Key: 243816058
• Report Number: 8030229-2020-00736
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102378
• 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: 02/02/2023

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-2304A
• Device Catalogue Number: BSM-2304A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 02/07/2021
• Supplement Dates Manufacturer Received: 01/19/2023
• Supplement Dates FDA Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2004
• 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