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

Catalog Number	2971000000
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient developed a deep tissue injury while on the surface.
Additional Manufacturer Narrative
Supplemental submitted to report the alleged injury was determined to be a stage 1 pressure injury based on conversation with the account.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 or Problem Description
It was reported the patient developed a stage 1 pressure injury while on the mattress.The nurse manager reported the injury was treated using venelex.

• Brand Name: ISOLIBRIUM SUPPORT SURFACE - N
• Common Device Name: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 7492186
• Report Number: 0001831750-2018-00455
• Device Sequence Number: 1677784
• Product Code: IKZ
• UDI-Device Identifier: 07613327278392
• UDI-Public: 07613327278392
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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?: No
• Operator of Device: No Information
• Device Catalogue Number: 2971000000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1