MAUDE Adverse Event Report: TELEFLEX INCORPORATED SOFTECH PLUS ETCO2 CANNULA; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number IPN044121

Device Problems Component Missing (2306); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 04/06/2021

Event Type  malfunction  

Event Description

Nasal canula with etco2 removed from packaging to connect to oxygen flowmeter.Line inspected and found to not have a co2 connector on end of line.Manufacturer response for etco2 nasal cannula, softech plus etco2 cannula (per site reporter) equipment failure reported to the manufacturer and waiting for response.Product available for return to manufacturer.

• Brand Name: SOFTECH PLUS ETCO2 CANNULA
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 11744328
• MDR Text Key: 247945454
• Report Number: 11744328
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2021,04/20/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN044121
• Device Catalogue Number: 2848
• Device Lot Number: 200076
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1