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

Model Number ZNCV4601HP-10

Device Problems Material Integrity Problem (2978); Pressure Problem (3012)

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

Event Date 03/28/2023

Event Type  malfunction  

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 Description

Wrong noninvasive pressure value on all systolic/diastolic/medium parameters (size 2, 3, 4, 5 cuffs).

Event Description

Wrong noninvasive pressure value on all systolic/diastolic/medium parameters (size 2, 3, 4, 5 cuffs).

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
• Type of Device: 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
• MDR Text Key: 334389500
• Report Number: 3000219639-2024-00008
• Device Sequence Number: 1
• Product Code: DXQ
• UDI-Device Identifier: 00607411911453
• UDI-Public: 00607411911453
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other