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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

This mdr is part of the fda voluntary malfunction summary reporting program.The device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 1 malfunction event, where it was reported the mattress slid off the stretcher.There was a patient on the mattress at the time of the event; however, no adverse consequences were reported.

Event Description

This report summarizes 1 malfunction event, where it was reported the mattress slid off the stretcher.There was a patient on the mattress at the time of the event; however, no adverse consequences were reported.

Manufacturer Narrative

It was originally reported that the mattress slid off the litter.However, it was determined through investigation that the mattress was only moving out of position.This issue is not reportable.

• 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
• MDR Report Key: 10344369
• MDR Text Key: 201053345
• Report Number: 0001831750-2020-00873
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

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: Health Professional
• Device Catalogue Number: 1805034300
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 07/01/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1