MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-1753A; VITAL SIGNS MONITOR

Model Number BSM-1753A

Device Problems Data Problem (3196); Patient Data Problem (3197)

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

Event Date 05/25/2023

Event Type  malfunction  

Event Description

The customer reported that the heart rate (hr) trace is going from one and then disappearing to going into two traces on this bedside monitor (bsm).There was no patient injury reported.

Manufacturer Narrative

The customer reported that the heart rate (hr) trace is going from one and then disappearing to going into two traces on this bedside monitor (bsm).The clinical specialist reviewed the issue and deemed that the unit needs to be send in to be repaired or exchanged.The customer is sending in the unit to be exchanged.There was no patient injury 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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6: attempt # 1: 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/07/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i will not provide any patient information.B6: attempt # 1: 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/07/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i will not provide any patient information.B7: attempt # 1: 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/07/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i will not provide any patient information.D10: attempt # 1: 06/05/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 06/07/2023 emailed the customer via microsoft outlook for device information: the customer replied by stating; i will not provide any patient information.

Event Description

The customer reported that the heart rate (hr) trace is going from one and then disappearing to going into two traces on this bedside monitor (bsm).There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the heart rate (hr) trace is going from one and then disappearing to going into two traces on this bedside monitor (bsm).The clinical specialist reviewed the issue and deemed that the unit needs to be send in to be repaired or exchanged.The customer is sending in the unit to be exchanged.There was no patient injury reported.Investigation summary: nihon kohden (nk) received the complaint device on 06/07/2023.Nk repair center evaluated the unit on 06/14/2023 and could not duplicate the complaint.Evaluation ran until 06/23/2023 with the unit on a simulator and the complaint still could not be duplicated.The unit did not show any errors.A definitive root cause could not be determined since the complaint could not be duplicated.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/07/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i will not provide any patient information.B6 attempt # 1: 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/07/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i will not provide any patient information.B7 attempt # 1: 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/07/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i will not provide any patient information.D10 attempt # 1: 06/05/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 06/07/2023 emailed the customer via microsoft outlook for device information: the customer replied by stating; i will not provide any patient information.The following fields are not available (n/a) to this report: h4 device manufacturer date additional information: b4 date of this report.D9 device available for evaluation? g3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h3 device evaluated by manufacturer? h10 additional manufacturer narrative.Manufacturer references # (b)(4).Follow up 001.

• Brand Name: BSM-1753A
• 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 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17108476
• MDR Text Key: 317360447
• Report Number: 8030229-2023-03613
• Device Sequence Number: 1
• Product Code: MHX
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

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-1753A
• Device Catalogue Number: BSM-1753A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: NI.; NI.