MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION LIFE SCOPE TR; VITAL SIGNS MONITOR

Model Number	MU-651RA
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported the bedside monitor (bsm) would spontaneously shut down intermittently.They tried inserting another bsm-1700 into this unit but received an "input unit failure" error message.It was not in patent use.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 the information were made, but not provided: d10 attempt # 1: on (b)(6) 2024 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: on (b)(6) 2024 emailed the bme for all information in the ni list above: no further information was provided in the bme's response.Additional device information: d10 concomitant medical device: the following devices was used in conjunction with the bsm: bsm-1700 model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) reported the bedside monitor (bsm) would spontaneously shut down intermittently.They tried inserting another bsm-1700 into this unit but received an "input unit failure" error message.It was not in patent use.
Event or Problem Description
The biomedical engineer (bme) reported the bedside monitor (bsm) would spontaneously shut down intermittently.They tried inserting another bsm-1700 into this unit but received an "input unit failure" error message.It was not in patent use.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported the bedside monitor (bsm) would spontaneously shut down intermittently.They tried inserting another bsm-1700 into this unit but received an "input unit failure" error message.It was not in patent use.Investigation summary: the reported issue could not be duplicated or confirmed after testing for 24 hours.Upon evaluation from the repair center, the unit had no visible damage but some scratches on the screen.The unit ran for 24 hours and was unable to duplicate the unit, shutting off the reported issue.The repair center stated this issue could be caused by a loose power cable, faulty outlet/power outlet failure, power outages or connection.Nk will continue to monitor and trend similar complaints.Udi related data quality updates.Corrected information: d1 brand name: corrected the brand name from bsm-6501a to life scope tr.D4 additional device information / model #: corrected the model # from bsm-6501a to mu-651ra.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, applicable to the unique device identifier (udi) information of the fda form 3500a.

• Brand Name: LIFE SCOPE TR
• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 19306556
• Report Number: 8030229-2024-04270
• Device Sequence Number: 6590285
• Product Code: MHX
• UDI-Device Identifier: 04931921103548
• UDI-Public: (01)04931921103548(21)6358
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/22/2024

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-651RA
• Device Catalogue Number: MU-651RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2020
• 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: BSM-1700; BSM-1700
• Patient Sex: Unknown