MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® DISPOSABLE GENERAL PURPOSE TEMPERATURE PROBE; THERMOMETER, ELECTRONIC, CLINICAL

Catalog Number ER400-9

Device Problem Use of Device Problem (1670)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 06/01/2018

Event Type  Injury  

Event Description

It was reported that during daily care, the ventilator tubing became dislodged from the endotracheal tube (ett).Because the connector for the ett fit well into the smiths medical temperature probe, the ventilator was inadvertently connected to the temperature probe; therefore, the temperature probe was ventilated.Approximately 10 minutes later, the patient coded, and this error was discovered.The patient was resuscitated and the condition resolved.

• Brand Name: LEVEL 1® DISPOSABLE GENERAL PURPOSE TEMPERATURE PROBE
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 1265 grey fox road; saint paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 7759281
• MDR Text Key: 116309707
• Report Number: 3012307300-2018-03348
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 30695085000444
• UDI-Public: 30695085000444
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K863646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ER400-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR