MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO XPRT MATTRESS W/O PENDANT; BED, PATIENT ROTATION, POWERED

Catalog Number 2950200000

Device Problem Insufficient Information (3190)

Patient Problem Tissue Breakdown (2681)

Event Date 03/18/2014

Event Type  Injury  

Event Description

It was reported via repair work order that allegedly the patient had skin break down.There was patient involvement; however, no clinically relevant delay in treatment was reported.

Manufacturer Narrative

Conclusion - the alleged product defect reported did not contribute to the reported injury.All secondary support functions were working correctly.However, a cell at the foot section of bed was not holding air properly so this assembly was replaced.The issue regarding sagging is a non-reportable.This will result in an annoyance only issue.Patient would be supported by secondary cells.

• Brand Name: XPRT MATTRESS W/O PENDANT
• Type of Device: BED, PATIENT ROTATION, 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: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3746081
• MDR Text Key: 4480998
• Report Number: 0001831750-2014-02879
• Device Sequence Number: 1
• Product Code: IKZ
• 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: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 2950200000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/18/2014
• 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