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

Catalog Number 1805034300

Device Problem Device Slipped (1584)

Patient Problem Fall (1848)

Event Date 08/29/2018

Event Type  malfunction  

Event Description

It was reported that the comfortgel mattress slid off the stretcher litter causing the patient to fall.The patient was not adversely affected and no 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7923813
• MDR Text Key: 122459046
• Report Number: 0001831750-2018-01071
• 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
• Report Date: 10/01/2018

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
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/03/2018
• 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