MAUDE Adverse Event Report: VYAIRE OY VITAL SIGNS; EG ATTACHMENT PAD

Model Number	2464MO-20
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that they are currently taping down the 2464aao-20 - leg attachment pad for corometrics fetal scalp electrode cable to the leg plate so that it will stay attached.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that they are currently taping down the 2464aao-20 - leg attachment pad for corometrics fetal scalp electrode cable to the leg plate so that it will stay attached.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Customer complained about leg attachment pads.It was confirmed, that changing the fse cable fixed the issue.The photo provided confirmed that the cable was of older revision, from previous supplier.Reviewed sha - rmf-hl-0060 - ob monitoring products - fse cables - rev06 - (b)(6) 2024.Closest risk could be sha-hl-0060-c-018 loss of function (e.G.Unexpected loss of mechanical or electrical integrity, fatigue failure), most probable cause failure of reusable product due to repeated and extensive use of product leading to loose connector fit.

• Brand Name: VITAL SIGNS
• Common Device Name: EG ATTACHMENT PAD
• Manufacturer (Section D): VYAIRE OY; kuortaneenkatu 2 helsinki ete; la-suomen laani; helsinki, ; FI
• Manufacturer (Section G): VYAIRE OY; kuortaneenkatu 2; helsinki uusimaa, fl NY FIN-0 0510; FI FIN-00510
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18637036
• Report Number: 3010838917-2024-00100
• Device Sequence Number: 18125304
• Product Code: DRX
• UDI-Device Identifier: 10190752188181
• UDI-Public: (01)10190752188181(10)354597
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2464MO-20
• Device Catalogue Number: 2464MO-20
• Device Lot Number: 354597
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 02/03/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 86 KG