MAUDE Adverse Event Report: SMITHS MEDICAL SWIVEL TRACH

Catalog Number 661991

Device Problem Misconnection (1399)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 05/22/2015

Event Type  Injury  

Event Description

The pt upon arrival in critical care was placed on a cardiac monitor which displayed pea.Cpr initiated; resuscitation efforts successful.During transport from pacu to critical care post recovery.The ambu bag was connected to the filter of the expiration port and not the inhalation port.This was discovered upon arrival in critical care by respiratory therapy.Pt remains unresponsive and ventilated.Documented in progress notes by the physician, pt has anoxic encephalopathy.

• Brand Name: SWIVEL TRACH
• Type of Device: SWIVEL TRACH
• Manufacturer (Section D): SMITHS MEDICAL; 5200 upper metro place; ste 200; dublin OH 43017
• MDR Report Key: 4866244
• MDR Text Key: 5810382
• Report Number: MW5043196
• Device Sequence Number: 3
• Product Code: JOH
• 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: 06/08/2015
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 661991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 73 YR