MAUDE Adverse Event Report: MEDTRONIC, INC. /COVIDIEN MEDTRONIC DAR/COVIDIEN MECHANICAL FILTER; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number 351U5979

Device Problem Obstruction of Flow (2423)

Patient Problems Low Oxygen Saturation (2477); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/26/2020

Event Type  Injury  

Event Description

After patient was emerging from anesthesia, etco2 lost and o2 sats dropped precipitously.Unable to move gases through filter due to suspected clogging with secretions.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC DAR/COVIDIEN MECHANICAL FILTER
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): MEDTRONIC, INC. /COVIDIEN; boulder CO 80301
• MDR Report Key: 10777758
• MDR Text Key: 214541638
• Report Number: MW5097609
• Device Sequence Number: 1
• Product Code: CAH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 351U5979
• Device Catalogue Number: 351U5979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Weight: 150