MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH; CIRCUIT, BREATHING (W CONNECTO

Catalog Number 1613

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: (b)(4).

Event Description

Customer reported the temperature probe port is not staying capped and therefore won't seal the ventilator circuit.The issue was detected prior to patient use.

Event Description

Customer reported the temperature probe port is not staying capped and therefore won't seal the ventilator circuit.The issue was detected prior to patient use.

Manufacturer Narrative

Continuation of d11: qn#(b)(4) one unit of catalog number 1613 (ventilator tubing set, long length) was received for analysis.The closure of the temperature port was inspected.The port was closed with the attached closure and no issues were observed.The temperature port was dimensionally inspected and no issues were observed.Functional testing was then performed and the sample passed the leak test.The temperature port was closed and remained closed without issues during the test.After functional testing the temperature port stayed closed for more than 24 hours and no issues was encountered.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.

• Brand Name: HUDSON VENTILATOR TUBING SET,LONG LENGTH
• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10519161
• MDR Text Key: 207431844
• Report Number: 3004365956-2020-00177
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1613
• Device Lot Number: 74C2000699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VENTILATORS - MEDTRONIC PURITAN BENNETT 980 AND 84.; VENTILATORS - MEDTRONIC PURITAN BENNETT 980 AND 84.