MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO COMFORTGEL SE FIRE BARR 30 IN; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 1805034301

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/20/2018

Event Type  malfunction  

Event Description

It was reported the mattress was sliding off the litter while a patient was on the device.No adverse consequences or clinically significant delays in treatment were reported.

Manufacturer Narrative

The issue was resolved for the customer by advising the customer on proper usage of the surface.

Event Description

It was reported the mattress was sliding off the litter while a patient was on the device.No adverse consequences or clinically significant delays in treatment were reported.

• Brand Name: COMFORTGEL SE FIRE BARR 30 IN
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7695808
• MDR Text Key: 114469286
• Report Number: 0001831750-2018-00709
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1805034301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/17/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1