MAUDE Adverse Event Report: MASIMO CORPORATION NIBP PATIENT HOSE, 3 METERS, MALE QUICK CONNECT; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Catalog Number 25247

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2018

Event Type  malfunction  

Event Description

Masimo nibp tubing part number 91-0028-69 connector becomes dislodged from the tubing when trying to disconnect tubing from the bp cuff.Once the connector is pulled out, the connection is loose and there is air leakage, and the cuff becomes easily disconnected.This makes taking the bp unreliable.

• Brand Name: NIBP PATIENT HOSE, 3 METERS, MALE QUICK CONNECT
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 7977078
• MDR Text Key: 124072589
• Report Number: 7977078
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25247
• Device Lot Number: A18C927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2018
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1