MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION AY-651P; INPUT UNIT FOR THE BEDSIDE MONITOR

Model Number	AY-651P
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that when they try to take a pressure, the screen gets a bunch of blue boxes that obscure the screen then the monitor shuts off.The customer tested the ay module with another bedside monitor and the issue followed the ay module.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.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the bedside monitor: life scope tr: model #:mu-631ra.(b)(6).Device manufacturer data: 06/16/2015.(b)(4).Returned to nihon kohden: no.
Event or Problem Description
The customer reported that when they try to take a pressure, the screen gets a bunch of blue boxes that obscure the screen then the monitor shuts off.There was no patient injury reported.
Event or Problem Description
The customer reported that when they try to take a pressure, the screen gets a bunch of blue boxes that obscure the screen then the monitor shuts off.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that when they try to take a pressure, the screen gets a bunch of blue boxes that obscure the screen then the monitor shuts off.The customer tested the ay module with another bedside monitor and the issue followed the ay module.There was no patient injury reported.Investigation summary: the returned device was evaluated and the reported issue could not be confirmed.A root cause could not be determined.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the bedside monitor: life scope tr: model #:mu-631ra serial #: (b)(6) device manufacturer data: 06/16/2015 unique identifier (udi) #: (b)(4) returned to nihon kohden: no.Additional information: b4 date of this report d9 is this device available for evaluation? g3 date received by manufacturer g6 type of report h2 if follow up, what type? h11 additional manufacturer narrative.

• Brand Name: AY-651P
• Common Device Name: INPUT UNIT FOR THE BEDSIDE 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: 22027383
• Report Number: 8030229-2025-04919
• Device Sequence Number: 17919450
• Product Code: MHX
• UDI-Device Identifier: 04931921101506
• UDI-Public: (01)04931921101506
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K213316
• 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): 08/05/2025

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: AY-651P
• Device Catalogue Number: AY-651P-QM
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2015
• 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: MU-631RA/LIFE SCOPE TR; MU-631RA/LIFE SCOPE TR
• Patient Sex: Unknown