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

Catalog Number 1805034301

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/30/2017

Event Type  malfunction  

Event Description

It was reported that the mattress was sliding on and off the stretcher with the patient during patient transfer.There was patient involvement, however no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was originally reported that the mattress would slide on and off the stretcher with the patient.However, upon investigation, it was found that the unit was moving out of position on the litter, and this may be caused by the user tucking sheets under the mattress between the surface and the litter.This issue was resolved for the customer by providing feedback to not tuck the sheets completely under the mattress and allow full contact for the mattress/litter.There was patient involvement, however no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported that the mattress was sliding on and off the stretcher with the patient during patient transfer.There was patient involvement, however no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was originally reported that the mattress would slide on and off the stretcher with the patient.However, upon investigation, it was found that the unit was moving out of position on the litter, and this may be caused by the user tucking sheets under the mattress between the surface and the litter.This issue was resolved for the customer by providing feedback to not tuck the sheets completely under the mattress and allow full contact for the mattress/litter.There was patient involvement, however no adverse consequence or clinically relevant delay in treatment was reported.This issue is not likely to cause or contribute to serious injury or death if it was to recur and is, therefore, not reportable.Supplemental submitted to include udi.

Event Description

It was reported that the mattress was sliding on and off the stretcher with the patient during patient transfer.There was patient involvement, however 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: 6530763
• MDR Text Key: 74078145
• Report Number: 0001831750-2017-00154
• 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: 03/30/2017
• Initial Date FDA Received: 04/28/2017
• Supplement Dates Manufacturer Received: 03/30/2017; 03/30/2017
• Supplement Dates FDA Received: 08/31/2017; 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