MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC COMFORT GLIDE LT; AIR MATTRESS FOR TRANSFER

Model Number MSC600LT

Device Problem Inflation Problem (1310)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2019

Event Type  malfunction  

Event Description

Attempted to use air mattress to move patient after c-section.Uneven distribution of weight due to air patient transfer mattress not blowing up properly.Possible injury to dr., nurse, and technician in transferring patient on mattress.

• Brand Name: COMFORT GLIDE LT
• Type of Device: AIR MATTRESS FOR TRANSFER
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; three lakes drive; northfield IL 60093
• MDR Report Key: 9256903
• MDR Text Key: 164325353
• Report Number: 9256903
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSC600LT
• Device Catalogue Number: MSC60011
• Device Lot Number: 1088827768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2019
• Date Report to Manufacturer: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12410 DA