MAUDE Adverse Event Report: AIRLIFE OY VITAL SIGNS; VITAL SIGNS¿ LEG ATTACHMENT PAD

Model Number	2464AAO-20
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All information reasonably known as of 11 sept 2024 has been included in this health authority report.Should additional.Information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all.Of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not.Be considered to be an admission that an airlife product is defective or caused serious injury.
Event or Problem Description
Cannot consistently attach the cable portion to the set to the attachment pad.It does not always snap into place.The adhesive also does not stick well.
Additional Manufacturer Narrative
All information reasonably known as of 11 sept 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint 10352.This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.The complaint of "cannot consistently attach the cable portion to the set to the attachment pad.It does not always snap into place.The adhesive also does not stick well." regarding part 2464aao-20 was not confirmed.The root cause was not determined but could possibly be a result of a combination of design and actions taken by the user.Design has been improved since the manufacturing of the related production lot, by improving snap tolerances, and changing the foam material for better adhesion.Customer has been notified of the importance of skin preparation and changing the cable at least every 1-2 years.A risk assessment was performed and the ultimate risk was determined to be low which does not require the initiation of a capa.There have been 25 other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
Event or Problem Description
Cannot consistently attach the cable portion to the set to the attachment pad.It does not always snap into place.The adhesive also does not stick well.

• Brand Name: VITAL SIGNS
• Common Device Name: VITAL SIGNS¿ LEG ATTACHMENT PAD
• Manufacturer (Section D): AIRLIFE OY; kuortaneenkatu 2; helsinki uusimaa, fl FIN-0 0510; FI FIN-00510
• Manufacturer (Section G): AIRLIFE OY; kuortaneenkatu 2; helsinki uusimaa, fl FIN-0 0510; FI FIN-00510
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 20195915
• Report Number: 3010838917-2024-00206
• Device Sequence Number: 17862376
• Product Code: DRX
• UDI-Device Identifier: 10190752188181
• UDI-Public: (01)10190752188181(10)342051
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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: 2464AAO-20
• Device Catalogue Number: 2464AAO-20
• Device Lot Number: 342051
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 0700180000-2024-8016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown