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

Model Number	BSM-3532A
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that they're getting communication loss on this bedside monitor.Technical service (ts) troubleshot the reported problem for a while and apparently everything is connected correctly.The customer will send in the unit for evaluation/repair.The customer requested a unit loaner.There was no patient injury reported.Additional model information: concomitant medical device: the following device was used in conjunction with the bedside monitor (bsm): central nurse's station (cns): model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: ni.
Event or Problem Description
The customer reported that they're getting communication loss on this bedside monitor.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported they were getting comm loss at the central nurse's station (cns) for this bedside monitor (bsm).No patient harm or injury was reported.Investigation summary: nihon kohden technical support (nk ts) performed troubleshooting steps.The host table for the cns was checked and the device was discharged and re admitted, with no success.Customer verified the network connections and switches in the network closet were in working order.Nk ts initiated and exchange.With the information available, a root cause cannot be determined.The issue was resolved with a replacement unit.
Event or Problem Description
The customer reported that they're getting communication loss on this bedside monitor.There was no patient injury reported.

• 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 ; 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: 12328860
• Report Number: 8030229-2021-01470
• Device Sequence Number: 4448025
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: 04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2021
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• 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: CNS; CNS
• Patient Sex: Unknown