MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION LIFE SCOPE TR; VITAL SIGN MONITOR (BSM-6701A)

Model Number	MU-671RA
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the bsm had a blank screen while in use.They can power on the device but cannot see anything on the screen.No patient harm was reported.The device was brought in for evaluation and repair on 06/12/2024.The reported problem was duplicated.The unit powered on, but the lcd screen remained all black.This unit has an older lcd model that we no longer support and will be upgraded to a new model with all the necessary parts for conversion.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 field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 06/05/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 06/24/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 07/02/2024 emailed the customer via microsoft outlook for all information in the ni list above: the customer replied that none of the requested information can be provided.
Event or Problem Description
The biomedical engineer (bme) reported that the bsm had a blank screen while in use.They can power on the device but cannot see anything on the screen.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer reported that the bsm had a blank screen while in use.They can power on the device but cannot see anything on the screen.No patient harm was reported.Investigation summary: the complaint device was received by nk on 06/12/2024 for evaluation and repair.The device was evaluated on 06/20/2024 and the complaint was duplicated.The unit powered on, but the lcd screen remained all black.The unit was also damaged on the rear and front enclosures.No fluid intrusion was observed.The lcd, touchscreen, interface board, operation panel, associated cables, and rear and front enclosures would need to be replaced to repair the device.The repair quote was updated due to the parts that need to be replaced.Multiple follow-up requests were sent to the customer, but they were unresponsive.The device has yet to be repaired due to lack of response from the customer.The cause of the issue was hardware component failure of the lcd and touchscreen, possibly from physical damage from user mishandling, electrical damage from outages or surges, or wear-and-tear which depends on device age and frequency of use.Review of the complaint device's serial number shows that the unit is 13 years old.Due to the age of the device, wear-and-tear may be a likely contributing factor to the component failure.Udi related data quality updates.Corrected information: d1 brand name: corrected the brand name from "bsm-6701a" to "life scope tr." d4 additional device information / model #: corrected the model # from bsm-6701a to mu-671ra.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.
Event or Problem Description
The biomedical engineer (bme) reported that the bsm had a blank screen while in use.They can power on the device but cannot see anything on the screen.No patient harm was reported.

• Brand Name: LIFE SCOPE TR
• Common Device Name: VITAL SIGN MONITOR (BSM-6701A)
• 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: 19662275
• Report Number: 8030229-2024-04364
• Device Sequence Number: 12411193
• Product Code: MHX
• UDI-Device Identifier: 04931921103562
• UDI-Public: (01)04931921103562(21)554
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: MU-671RA
• Device Catalogue Number: MU-671RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2010
• 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
• Patient Sex: Unknown