MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION AY-633P; INPUT UNIT, 3 MULTI CONNECTOR, MASIMO SPO2

Model Number	AY-633P
Medical Device Problem Codes	Unable to Obtain Readings (1516); Low Readings (2460); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the ay input unit connected to the bedside monitor (bsm) was giving low or no spo2 readings.The nurses confirmed the spo2 readings to be 10% below normal readings.
Additional Manufacturer Narrative
The customer reported that the ay input unit connected to the bedside monitor (bsm) was giving low or no spo2 readings.The nurses confirmed the spo2 readings to be 10% below normal readings.They tested the ay input unit on another bsm, and the issue persisted.No harm or injury was reported.They would like to send this unit in for repair.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 information were made, but not provided: patient information, brand name, model number, catalog number, serial number, udi number, pma / 510k number, device manufacture date.Additional model information: concomitant medical device: the following device was being used in conjunction with the ay input unit and is not the device that experienced the failure: bsm: model #: ni, sn #: ni.Attempt # 1: 10/18/2022 emailed the customer for patient and concomitant device information: no reply was received.Attempt # 2: 10/24/2022 emailed the customer for patient and concomitant device information: no reply was received.Attempt # 3: 11/02/2022 emailed the customer for patient and concomitant device information: no reply was received.
Event or Problem Description
The customer reported that the ay input unit connected to the bedside monitor (bsm) was giving low or no spo2 readings.The nurses confirmed the spo2 readings to be 10% below normal readings.No patient harm or injury was reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the ay input unit connected to the bedside monitor (bsm) was giving low or no spo2 readings.The nurses confirmed the spo2 readings to be 10% below normal readings.They tested the ay input unit on another bsm, and the issue persisted.No patient harm or injury was reported.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.The customer was contacted multiple times for a device return but the requests were left unanswered.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal similar complaints.The device was installed in october of 2011 with no history of servicing.The root cause is likely related to wear and tear due to aging.Additional model information: d10: concomitant medical device: the following device was used in conjunction with the ay input unit and is not the device that experienced the failure: bsm: model #: ni.Sn #: ni.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.H10 additional manufacturer narrative.
Additional Manufacturer Narrative
Udi related data quality updates.Corrected information: d1 brand name: corrected the brand name from ni to ay-633p.D4 additional device information / model #: corrected the model # from ni to ay-633p.D4 additional device information / catalog #: corrected the catalog # from ni to ay-633p-qm.D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (pi) information.G4 premarket identification / pma/510(k) number: corrected the 510(k) # from ni to k213316.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.Additional information: b4 data of this report.G6 type of report.H2 if follow up, what type?.
Event or Problem Description
The customer reported that the ay input unit connected to the bedside monitor (bsm) was giving low or no spo2 readings.The nurses confirmed the spo2 readings to be 10% below normal readings.No patient harm or injury was reported.

• Brand Name: AY-633P
• Common Device Name: INPUT UNIT, 3 MULTI CONNECTOR, MASIMO SPO2
• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 15764834
• Report Number: 8030229-2022-03191
• Device Sequence Number: 12350620
• Product Code: MHX
• UDI-Device Identifier: 04931921101490
• UDI-Public: (01)04931921101490
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,Followup
• Report Date (Section B): 08/15/2024

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: AY-633P
• Device Catalogue Number: AY-633P-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: 10/14/2022
• Supplement Date Received by Manufacturer: 11/30/2023; 11/30/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/01/2023; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; BSM
• Patient Sex: Unknown