MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ULTRA COMFORT, SE 4 X 26; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 1704034600

Device Problem Device Slipped (1584)

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

Event Date 11/22/2017

Event Type  malfunction  

Event Description

It was alleged that the mattress is not holding and came off of the stretcher during patient transfer.No adverse consequences were reported to the patient or caregiver.

Manufacturer Narrative

Although no defect was found, a review of previous similar complaints and a labeling review identified that a possible cause for this issue may be attributed to use error as the velcro on the mattress may not be properly aligned with the velcro on the litter by the operator, leading to a decreased adhesion surface area and decreased hold.The sales account manager, provided feedback on proper alignment of the velcro and proper transfer methods to alleviate the issue.

Event Description

It was alleged that the mattress is not holding and came off of the stretcher during patient transfer.No adverse consequences were reported to the patient or caregiver.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It was alleged that the mattress is not holding and came off of the stretcher during patient transfer.No adverse consequences were reported to the patient or caregiver.

• Brand Name: ULTRA COMFORT, SE 4 X 26
• 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: 7131366
• MDR Text Key: 95498470
• Report Number: 0001831750-2017-00579
• 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 Health Care Professional
• 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: 1704034600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 11/22/2017; 11/22/2017
• Supplement Dates FDA Received: 01/31/2018; 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