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

Model Number	AY-651P
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the ay input unit had non-invasive blood pressure (nibp) discrepancies.Clinical staff have observed inconsistent nibp readings when taken back-to-back.The values fluctuated significantly.As a result, nibp was being taken manually.No patient harm has been 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 was used in conjunction with the input unit: bsm, model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.
Event or Problem Description
The customer reported that the ay input unit had non-invasive blood pressure (nibp) discrepancies.No patient harm or injury was reported.
Event or Problem Description
The customer reported that the ay input unit had non-invasive blood pressure (nibp) discrepancies.No patient harm or injury was reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the ay input unit had non-invasive blood pressure (nibp) discrepancies.Clinical staff have observed inconsistent nibp readings when taken back-to-back.The values fluctuated significantly.As a result, nibp was being taken manually.No patient harm has been reported.Investigation summary: review of the complaint device's serial number shows that the unit was over 15 years old.Due to the age of the device, wear-and-tear may be a likely contributing factor to potential hardware failure.The customer replied that they replaced the unit and the ticket can be closed.The unit was not replaced through nk service.The complaint device would not be returned to nk.Root cause could not be determined.Nk will continue to monitor and trend.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the input unit: bsm model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes 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: 22716003
• Report Number: 8030229-2025-05274
• Device Sequence Number: 9611866
• Product Code: MHX
• UDI-Device Identifier: 04931921101506
• UDI-Public: (01)04931921101506
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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-651P
• Device Catalogue Number: AY-651P-QM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2009
• 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