MAUDE Adverse Event Report: MALLINKRODT INFANT REUSABLE SENSOR

Catalog Number MAXIR

Device Problem Insufficient Information (3190)

Patient Problem Choking (2464)

Event Date 11/23/2013

Event Type  Injury  

Event Description

Patient choked on tag on the reusable mallinckrodt sensor.

• Brand Name: INFANT REUSABLE SENSOR
• Type of Device: REUSABLE SENSOR
• Manufacturer (Section D): MALLINKRODT
• MDR Report Key: 3658243
• MDR Text Key: 4199251
• Report Number: MW5034776
• Device Sequence Number: 1
• Product Code: FLL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MAXIR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 1 YR
• Patient Weight: 9