MAUDE Adverse Event Report: SALTER LABS SALTER LABS; CUFF NEOCHECK VINYL #2-5 1T HP

Model Number	ZNCV4601HP-10
Medical Device Problem Codes	Material Integrity Problem (2978); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bp cuff malfunction clip on attachment for an adult cuff would delay the reading of the neonate, but the clinician would be able to recognize the deficiency before use of the product and change it out with the correct one.There was no report that a patient was impacted by product deficiency.
Event or Problem Description
Wrong noninvasive pressure value on all systolic/diastolic/medium parameters (size 2, 3, 4, 5 cuffs).
Event or Problem Description
Wrong noninvasive pressure value on all systolic/diastolic/medium parameters (size 2, 3, 4, 5 cuffs).
Additional Manufacturer Narrative
The bp cuff malfunction clip on attachment for an adult cuff would delay the reading of the neonate, but the clinician would be able to recognize the deficiency before use of the product and change it out with the correct one.There was no report that a patient was impacted by product deficiency.The complaint of inaccurate bp readings regarding parts zncv4601hp-10, zncv4701hp-10, zncv4801hp-10, zncv4901hp-10 was not confirmed.The root cause was not determined but could possibly be a result of a kink or collapse of cuff tubing to system line.A risk assessment was performed and the ultimate risk was determined to be medium which would require reporting to the capa review board, but this product has been discontinued.There have been 5 other complaints regarding the same part and a similar issue within the 24 months preceding the reporting of this issue.A resolution letter was sent to the customer.

• Brand Name: SALTER LABS
• Common Device Name: CUFF NEOCHECK VINYL #2-5 1T HP
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18627615
• Report Number: 3000219639-2024-00008
• Device Sequence Number: 7889381
• Product Code: DXQ
• UDI-Device Identifier: 00607411911453
• UDI-Public: 00607411911453
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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: ZNCV4601HP-10
• Device Catalogue Number: ZNCV4601HP-10
• Device Lot Number: 360966
• 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: 01/02/2024
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/20/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown