MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO XPRT SLEEP SURFACE; BED, PATIENT ROTATION, POWERED

Catalog Number 2950000000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pressure Sores (2326)

Event Date 08/18/2014

Event Type  Injury  

Event Description

It was alleged a patient developed an unstageable hospital-acquired pressure ulcer on his/her left heel.

Manufacturer Narrative

A visual and functional inspection was not performed as the mattress could not be identified for evaluation.No allegations of a malfunction were reported.A stryker clinical specialist visited the account to perform rounds on (b)(4) 2014 in the icu at the user facility.Based on her observation the following is a summary of her visit: 1.Patients were not rotated every two hours.2.Patient heels were not floated (raised up off the mattress at the calf).3.Some patients were critically ill or at end of life.4.The staff were not using the correct firmness settings on the xprt mattresses.5.The staff were not aware of the braden scale ratings.6.There was inconsistent notation of patients admitted with pre-existing pressure ulcers and hospital acquired pressure ulcers (hapu).The unit could not be identified for evaluation.

• Brand Name: XPRT SLEEP SURFACE
• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 4111813
• MDR Text Key: 4703732
• Report Number: 0001831750-2014-03270
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 2950000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: No
• 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