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 Injury (2348)

Event Date 07/24/2018

Event Type  Injury  

Manufacturer Narrative

In a conversation between stryker medical and an employee health nurse at the user facility, the nurse was reminded that cleaning under the mattress should utilize 2 people in order to reduce the risk of injury, as stated in the manual.The serial number of the unit involved in the reported incident was not recorded by the user facility, therefore the unit could not evaluated.However, the user facility is not alleging a product malfunction.

Event Description

It was reported that an evs employee sustained an injury during a discharge cleaning.The employee reported lifted the foot end of the mattress and did not want to completely unplug and disconnect the unit before cleaning, which resulted in a strained lower back due to the weight of the mattress and pump.The injured employee has undergone physical therapy, and taken medications for pain management.

• 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: 7800471
• MDR Text Key: 117694909
• Report Number: 0001831750-2018-00986
• 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: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• 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: 07/24/2018
• 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