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

Device Problems Unable to Obtain Readings (1516); Low Readings (2460); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2022

Event Type  malfunction  

Event 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.

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 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.

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.

• Brand Name: NI
• Type of Device: 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 15764834
• MDR Text Key: 307892800
• Report Number: 8030229-2022-03191
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BSM; BSM