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

Catalog Number 1805034300

Device Problem Use of Device Problem (1670)

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

Event Date 05/21/2018

Event Type  malfunction  

Event Description

The customer reported that the mattresses allegedly slid off the stretcher.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Information provide by the user facility identified that this was a user preference issue and that no device malfunction had occurred.

Event Description

The customer reported that the mattresses allegedly slid off the stretcher.No patient was affected and no adverse consequence or 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: 7608247
• MDR Text Key: 111853499
• Report Number: 0001831750-2018-00586
• 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
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2018
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2018
• 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