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

Catalog Number 1805034301

Device Problem Component Missing (2306)

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

Event Date 03/27/2017

Event Type  malfunction  

Event Description

It was alleged by the customer that with no sheets on the mattress, the mattress seems to stay in place but when they tuck the sheets under the mattress they slip and could allow the mattress to slide off the litter.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Upon completion of the device evaluation.It was confirmed that the mattress was not sliding off from the stretcher and that no defect was identified with the mattress.

Event Description

It was alleged by the customer that with no sheets on the mattress, the mattress seems to stay in place but when they tuck the sheets under the mattress they slip and could allow the mattress to slide off the litter.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It was alleged by the customer that with no sheets on the mattress, the mattress seems to stay in place but when they tuck the sheets under the mattress they slip and could allow the mattress to slide off the litter.No patient was affected and no adverse consequence or clinically relevant delay in treatment was 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: 6516339
• MDR Text Key: 73731120
• Report Number: 0001831750-2017-00136
• 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,Followup
• Report Date: 03/26/2018

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: 03/27/2017
• Initial Date FDA Received: 04/24/2017
• Supplement Dates Manufacturer Received: 03/27/2017; 03/27/2017
• Supplement Dates FDA Received: 08/28/2017; 03/26/2018
• 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