MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION AY-653P; INPUT UNIT FOR THE BEDSIDE MONITOR

Model Number	AY-653P
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the ay input unit connected to the bedside monitor (bsm) was not taking blood pressure and electrocardiogram (ecg) readings while it was hooked up to a patient.No patient harm or injury was 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 ay input unit: bsm: model #: mu-631ra serial #: (b)(6).Device manufacturer data: 08/07/2020 unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.
Event or Problem Description
The customer reported that the ay input unit connected to the bedside monitor (bsm) was not taking blood pressure and electrocardiogram (ecg) readings while it was hooked up to a patient.No patient harm or injury was reported.
Additional Manufacturer Narrative
Incident summary: the customer reported that the ay input unit connected to the bedside monitor (bsm) was not taking blood pressure and electrocardiogram (ecg) readings while it was hooked up to a patient.No patient harm or injury was reported.Investigation summary: the complaint device was received by nihon kohden.The unit was evaluated and the complaint could not be duplicated.No visible damage or fluid intrusion found.The unit passed all functional tests.A definitive root cause could not be determined since we could not duplicate the complaint during evaluation.Possible causes may include user error with device set-up such as incomplete connection of the nibp and ecg cables, incomplete connection of the input unit, or use of damaged or third-party accessories not specified for use with the nihon kohden device.Review of the complaint device's serial number shows 1 previous similar complaint in which the nibp issue could not be duplicated during evaluation.
Event or Problem Description
The customer reported that the ay input unit connected to the bedside monitor (bsm) was not taking blood pressure and electrocardiogram (ecg) readings while it was hooked up to a patient.No patient harm or injury was reported.

• Brand Name: AY-653P
• 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: 21097758
• Report Number: 8030229-2025-04631
• Device Sequence Number: 8775890
• Product Code: MHX
• UDI-Device Identifier: 04931921101513
• UDI-Public: (01)04931921101513
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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-653P
• Device Catalogue Number: AY-653P-QM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2020
• 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.; BSM.
• Patient Sex: Unknown