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

Catalog Number 1805034300

Device Problem Detachment Of Device Component (1104)

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

Event Date 09/02/2017

Event Type  malfunction  

Event Description

It was reported that while transferring a patient onto the stretcher the mattress slid completely off.The patient was not harmed and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

The issue was attributed to the account using flat sheets that were tucked under the mattress therefore reducing the grip from the litter/frame with the mattress.The issue was resolved for the customer by providing feedback on proper use of sheets on the mattress and explaining the importance of contact between the bottom of the mattress and the litter of the stretcher.

Event Description

It was reported that while transferring a patient onto the stretcher the mattress slid completely off.The patient was not harmed and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It was reported that while transferring a patient onto the stretcher the mattress slid completely off.The patient was not harmed and no adverse consequence or clinically relevant delay in treatment was reported.

• 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: 6917910
• MDR Text Key: 89698883
• Report Number: 0001831750-2017-00436
• 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: health professional
• Reporter Occupation: Nurse
• 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: 1805034300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 10/05/2017
• Supplement Dates Manufacturer Received: 09/07/2017; 09/07/2017
• Supplement Dates FDA Received: 10/25/2017; 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