MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-3532A; VITAL SIGNS MONITOR

Model Number	BSM-3532A
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the bedside monitor (bsm) fell from the wall mount it was attached to.The mount was not correctly mounted into the wall studs, and the device fell from about 5 feet up.No harm or injury was reported.They would like to send the unit in to fix the physical damage.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.Additional device information: concomitant medical device: the following device was used in conjunction with the bsm and is the device that experienced the failure: wall support bracket: model #: the customer could not provide this information.Serial #: the customer could not provide this information.
Event or Problem Description
The customer reported that the bedside monitor (bsm) fell from the wall mount it was attached to.The mount was not correctly mounted into the wall studs, and the device fell from about 5 feet up.No harm or injury was reported.
Event or Problem Description
The customer reported that the bedside monitor (bsm) fell from the wall mount it was attached to.The mount was not correctly mounted into the wall studs, and the device fell from about 5 feet up.No harm or injury was reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the bedside monitor (bsm) fell from the wall mount it was attached to.The mount was not correctly mounted into the wall studs, and the device fell from about 5 feet up.No patient harm or injury was reported.Investigation summary: the customer stated that their maintenance personnel installed the mount and that the mount was not correctly mounted into the studs of the wall.No injuries were reported.Based on the available information, the most probable cause of the issue is user error - incorrect installation.Should the mount have been properly installed, the issue may have been prevented.

• Brand Name: BSM-3532A
• 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 ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 16065194
• Report Number: 8030229-2022-03265
• Device Sequence Number: 2034031
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: 04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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
• Operator of Device: Health Professional
• Device Model Number: BSM-3532A
• Device Catalogue Number: BSM-3532A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WALL SUPPORT BRACKET; WALL SUPPORT BRACKET
• Patient Sex: Unknown