MAUDE Adverse Event Report: MEDEX CARDIO-PULMONARY INC PORTEX 300 ML PRE-FILLED HUMIDIFIER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PT INTERFACE)

Catalog Number 0352

Device Problem Occlusion Within Device (1423)

Patient Problems Hypoventilation (1916); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

Distributor reported on behalf of user facility that while the device was in use with a pt, little or no oxygen was reaching the pt.The user facility reported that the pt decompensated and was admitted to the hosp.After a few days, the pt was returned to the user facility and decompensated again.The user facility reported that the device opening was not wide enough, preventing appropriate flow of oxygen.It was reported that the nurse cut away some plastic at the device opening and the pt's condition improved.No permanent adverse effects to the pt were reported.

Manufacturer Narrative

Customer has not yet returned the device to the mfr for device eval.When and if the device becomes available and is returned and evaluated, the mfr will file a follow up report detailing the results of the eval.

• Brand Name: PORTEX 300 ML PRE-FILLED HUMIDIFIER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PT INTERFACE)
• Manufacturer (Section D): MEDEX CARDIO-PULMONARY INC; vernon hills IL
• Manufacturer (Section G): MEDEX CARDIO PULMONARY INC; 330 corporate woods parkway; vernon hills IL 60061
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4009401
• MDR Text Key: 4688482
• Report Number: 2183502-2014-00542
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 08/01/2014
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization