MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX 35X84 DARTEX W/FB; BED, FLOTATION THERAPY, POWERED

Catalog Number 2800100000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 12/06/2018

Event Type  Injury  

Event Description

It was reported an end-of-life patient experienced a pressure injury while lying on the surface.The patient did not receive treatment for the injury, and was likely not rotated on the mattress, as they were end-of-life.No malfunction of the surface was reported.

• Brand Name: ISOFLEX 35X84 DARTEX W/FB
• Type of Device: BED, FLOTATION THERAPY, 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8217836
• MDR Text Key: 132207591
• Report Number: 0001831750-2019-00001
• Device Sequence Number: 1
• Product Code: IOQ
• 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: 01/04/2019

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?: No
• Device Operator: No Information
• Device Catalogue Number: 2800100000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 01/04/2019
• 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
• Patient Outcome(s): Other