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

Model Number	BSM-6501A
Medical Device Problem Codes	Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that they were having issues with the unit intermittently shutting down.This will happen randomly, while the unit is connected to power via ac or battery.They stated that the problem will continue to happen even after attempting a proper reboot.The unit was returned for evaluation.The repair center duplicated the issue, and there was physical damage to front enclosure.The lcd touchscreen was replaced and tested.Then it operated to manufacturer's specifications.Not in patient use.The overall risk score is medium.Based on the nihon kohden repair center evaluation, the bsm 6000 was rebooting due to malfunctioning of the lcd assembly.The bsm-6000 was installed at the customer facility in 09/2011.A serial number review of the unit in question reveals no prior complaints or servicing history.As such, the root cause for the intermittent rebooting is most likely a result of hardware failure due to normal wear and tear.
Event or Problem Description
The biomedical engineer (bme) reported that they were having issues with the unit intermittently shutting down.This will happen randomly, while the unit is connected to power via ac or battery.They stated that the problem will continue to happen even after attempting a proper reboot.The unit was returned for evaluation.The repair center duplicated the issue, and there was physical damage to front enclosure.The lcd touchscreen was replaced and tested.Then it operated to manufacturer's specifications.Not in patient use.

• Brand Name: BSM-6501A
• Common Device Name: 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: 14440880
• Report Number: 8030229-2022-02836
• Device Sequence Number: 17400732
• Product Code: MHX
• UDI-Device Identifier: 04931921103548
• UDI-Public: 04931921103548
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

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
• Operator of Device: Health Professional
• Device Model Number: BSM-6501A
• Device Catalogue Number: MU-651RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown