MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ULTRA COMFRT, SE 4X30 DOMESTIC; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 1704034300

Device Problem Device Slipped (1584)

Patient Problem Injury (2348)

Event Date 02/14/2020

Event Type  Injury  

Event Description

It was reported by medwatch form 3500 submitted by the user facility that during transfer of a patient from a stretcher to an operating room (or) table, the mattress slid with the patient and the patient was subsequently stuck between the stretcher and operating room (or) table.The staff successfully transferred the patient, however a contracted employee sustained an unknown muscular/skeletal injury.No injury was reported for the patient.

Event Description

It was reported by medwatch form 3500 submitted by the user facility that during transfer of a patient from a stretcher to an or table, the mattress slid with the patient and the patient was subsequently stuck between the stretcher and or table.The staff successfully transferred the patient, however a contracted employee sustained an unknown muscular/skeletal injury.No injury was reported for the patient.

Manufacturer Narrative

This event was not due to any specific component malfunction.

• Brand Name: ULTRA COMFRT, SE 4X30 DOMESTIC
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 9831485
• MDR Text Key: 183368193
• Report Number: 0001831750-2020-00313
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1704034300
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other