MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM SUPPORT SURFACE - N; BED, PATIENT ROTATION, POWERED

Catalog Number 2971000000

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

The nurse manager indicated she believed the injury may be attributed to the mattress cycling out of prevention mode.She was informed by a stryker quality assurance engineer that the mattress may leave prevention mode if the power of the unit is cycled and patient therapy settings are not reselected.The nurse manager reported the account is working on training measures to educate nurses to check to make sure the bed is in prevention mode.No device malfunction is alleged.

Event Description

It was reported the patient developed a stage 3 pressure injury while on the mattress.The nurse manager reported the injury was treated using venelex.

• Brand Name: ISOLIBRIUM SUPPORT SURFACE - N
• 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: 7503479
• MDR Text Key: 107892518
• Report Number: 0001831750-2018-00469
• Device Sequence Number: 1
• Product Code: IKZ
• UDI-Device Identifier: 07613327278392
• UDI-Public: 07613327278392
• 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: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 2971000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/08/2018
• 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