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

MAUDE Adverse Event Report: NULL PORTEX CUFF INFLATOR PRESSURE GAUGE; PRESSURE MONITORING (AIR/GAS) KIT

  • 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
 

NULL PORTEX CUFF INFLATOR PRESSURE GAUGE; PRESSURE MONITORING (AIR/GAS) KIT Back to Search Results
Catalog Number 100/568/000
Device Problem Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the parameters are incorrect of where the cuff pressure should be.No patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PORTEX CUFF INFLATOR PRESSURE GAUGE
Type of Device
PRESSURE MONITORING (AIR/GAS) KIT
Manufacturer (Section G)
NULL
MDR Report Key14186715
MDR Text Key294013525
Report Number3012307300-2022-06851
Device Sequence Number1
Product Code PXE
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial
Report Date 04/22/2022
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? No
Device Operator Health Professional
Device Catalogue Number100/568/000
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/28/2022
Initial Date FDA Received04/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-2401-2021
Patient Sequence Number1
-
-