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

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.

• Brand Name: PORTEX CUFF INFLATOR PRESSURE GAUGE
• Type of Device: PRESSURE MONITORING (AIR/GAS) KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 14186715
• MDR Text Key: 294013525
• Report Number: 3012307300-2022-06851
• Device Sequence Number: 1
• Product Code: PXE
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• 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 Number: 100/568/000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/22/2022
• 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 Number: Z-2401-2021
• Patient Sequence Number: 1