MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO COMFGEL SE W/O FIRE BAR, 30IN; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 1805034300

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/09/2018

Event Type  malfunction  

Event Description

It was alleged that the mattress slid off from the frame of the stretcher with the patient.The customer alleges the patient was exiting the stretcher at the time of the event.No medical intervention or serious injury occurred as a result of this event.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It was alleged that the mattress slid off from the frame of the stretcher with the patient.The customer alleges the patient was exiting the stretcher at the time of the event.No medical intervention or serious injury occurred as a result of this event.

Manufacturer Narrative

The device evaluation identified that the user facility uses flat sheets on their surfaces and tucks the sheets underneath.The user facility was provided with feedback regarding the importance of the contact of the bottom surface with the litter surface and proper sheet usage.

Event Description

It was alleged that the mattress slid off from the frame of the stretcher with the patient.The customer alleges the patient was exiting the stretcher at the time of the event.No medical intervention or serious injury occurred as a result of this event.

• Brand Name: COMFGEL SE W/O FIRE BAR, 30IN
• 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: 7239044
• MDR Text Key: 99088648
• Report Number: 0001831750-2018-00073
• 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: 03/23/2018

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: 1805034300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 01/09/2018; 01/09/2018
• Supplement Dates FDA Received: 03/05/2018; 03/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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