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 Consequences Or Impact To Patient (2199)

Event Date 03/23/2017

Event Type  malfunction  

Event Description

It was alleged that while transferring a patient with a transfer board, the mattress lifted up almost entirely on the one side and dropped back down when the patients body weight shifted.The staff caught the mattress with the transfer board.Neither the patient or the staff members were injured.

Manufacturer Narrative

The customer alleged that there was no malfunctions with the product and reported that the cause as to why the mattress had slid with the the roller was due to the the weight of the patient.

Event Description

It was alleged that while transferring a patient with a transfer board, the mattress lifted up almost entirely on the one side and dropped back down when the patients body weight shifted.The staff caught the mattress with the transfer board.Neither the patient or the staff members were injured.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It was alleged that while transferring a patient with a transfer board, the mattress lifted up almost entirely on the one side and dropped back down when the patients body weight shifted.The staff caught the mattress with the transfer board.Neither the patient or the staff members were injured.

• 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: 6513226
• MDR Text Key: 73670584
• Report Number: 0001831750-2017-00135
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,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: 03/26/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: Not provided; 03/26/2017
• Supplement Dates FDA Received: 06/22/2017; 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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