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 Bruise/Contusion (1754); Fall (1848)

Event Date 07/20/2018

Event Type  malfunction  

Event Description

It was reported that the customer was performing a patient transfer when the mattress slid off from the stretcher resulting in a patient fall.It was reported that the patient received a bruised shoulder.

Manufacturer Narrative

The alleged fall happened when transferring a larger patient onto a stretcher using a hover mat.The stretcher was in a high position and the hover mat contacted the mattress moving it over so that it was partially off the stretcher.The customer didn't notice this and placed the patient onto the mattress which then fell off with the patient.The patient said they were ok but bruised their shoulder.

Event Description

It was reported that the customer was performing a patient transfer when the mattress slid off from the stretcher resulting in a patient fall.It was reported that the patient received a bruised shoulder.

• 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: 7781955
• MDR Text Key: 117290652
• Report Number: 0001831750-2018-00969
• 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: 09/20/2018

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: 1805034300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/14/2018
• Supplement Dates Manufacturer Received: 07/20/2018
• Supplement Dates FDA Received: 09/20/2018
• 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