MAUDE Adverse Event Report: MIRANDOLA-RX MALLINCKRODT; HYGROBAC S ELECST FHME X25

Catalog Number 352/5877

Device Problem Complete Blockage (1094)

Patient Problem Fainting (1847)

Event Date 05/30/2016

Event Type  Injury  

Manufacturer Narrative

Covidien/medtronic reference number: (b)(4).

Event Description

After 5 hours of ventilating, the filter was clogged.The patient fainted due to hypoventilation.The breathing circuit and filter was replaced.The filter was tested and inspected prior to use.

• Brand Name: MALLINCKRODT
• Type of Device: HYGROBAC S ELECST FHME X25
• Manufacturer (Section D): MIRANDOLA-RX; via bove, 2; i-41037; mirandola ; IT
• Manufacturer (Section G): COVIDIEN; via bove, 2; i-41037; mirandola ; IT
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5724200
• MDR Text Key: 47396052
• Report Number: 2936999-2016-00480
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K941381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/31/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 352/5877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/31/2016
• Initial Date FDA Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR