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

Model Number BSM-3532A

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907); Device Fell (4014)

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

Event Date 12/02/2022

Event Type  malfunction  

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 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 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.

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
• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 16065194
• MDR Text Key: 308349230
• Report Number: 8030229-2022-03265
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: 04931921113660
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: BSM-3532A
• Device Catalogue Number: BSM-3532A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2018
• 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: WALL SUPPORT BRACKET; WALL SUPPORT BRACKET