• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MASIMO CORPORATION NIBP PATIENT HOSE, 3 METERS, MALE QUICK CONNECT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Catalog Number 25247
Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Gas 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNIBP PATIENT HOSE, 3 METERS, MALE QUICK CONNECT
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
MASIMO CORPORATION
52 discovery
irvine CA 92618
MDR Report Key7977078
MDR Text Key124072589
Report Number7977078
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received10/18/2018
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number25247
Device Lot NumberA18C927
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/28/2018
Device Age1 MO
Event Location Hospital
Date Report to Manufacturer10/18/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-