MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION LIFE SCOPE TR; VITAL SIGNS MONITOR (BSM-6300 MAIN UNIT)

Model Number MU-631RA

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 10/09/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this bedside monitor went into a white screen while monitoring a patient.The customer tried to reboot it by removing the battery, replacing the battery and plugging it into the wall; however, the issue remained.The customer will send 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.

Event Description

The customer reported that this bedside monitor went into a white screen while monitoring a patient.There was no patient injury reported.

Event Description

The customer reported that this bedside monitor went into a white screen while monitoring a patient.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that this bedside monitor went into a white screen while monitoring a patient.The customer tried to reboot it by removing the battery, replacing the battery and plugging it into the wall; however, the issue remained.The customer will send in the unit to be exchanged.There was no patient injury reported.Investigation summary: nihon kohden (nk) repair center evaluated the device, the reported issue was duplicated and confirmed.The touchscreen and the touch screen packing were replaced to resolve the issue.A definitive root cause could not be determined as to why these components were defective.Attempt # 1: 10/18/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 10/20/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i'm not able to answer any of the questions.Attempt # 1: 10/18/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 10/20/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i'm not able to answer any of the questions.B7 attempt # 1: 10/18/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 10/20/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i'm not able to answer any of the questions.D10 attempt # 1: 10/18/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 10/20/2023 emailed the customer via microsoft outlook for device information: the customer replied by stating; i'm not able to answer any of the questions.Manufacturer references # (b)(4)- 189418 follow up 001.

Event Description

The customer reported that this bedside monitor went into a white screen while monitoring a patient.There was no patient injury reported.

Manufacturer Narrative

Udi related data quality updates.Corrected information: d1 brand name: corrected the brand name from bsm-6301a to life scope tr.D4 additional device information / model #: corrected the model # from bsm-6301a to mu-631ra.D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the pi information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.

• Brand Name: LIFE SCOPE TR
• Type of Device: VITAL SIGNS MONITOR (BSM-6300 MAIN UNIT)
• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18065741
• MDR Text Key: 327290327
• Report Number: 8030229-2023-03838
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: (01)04931921103517(21)21884
• 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,Followup
• Report Date: 08/06/2024

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: MU-631RA
• Device Catalogue Number: MU-631RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 01/11/2024; 01/11/2024
• Supplement Dates FDA Received: 01/15/2024; 08/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2021
• 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