MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX LAL,2860, W/MEDSURG; BED, FLOTATION THERAPY, POWERED

Catalog Number 2860000997

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

The serial number of the unit involved in the alleged event was not recorded, therefore no evaluation could be performed.However, the account was not alleging a product malfunction.Rather, the nurse manager indicated they believe the event occurred due to the patient not being rotated/turned frequently enough.Serial number of unit involved in alleged event was not recorded.

Event Description

It was reported the patient developed a deep tissue injury on the lower spine area which required medication.No additional information regarding medical intervention was reported.The nurse manager at the account reported they attributed the alleged injury to the patient not being turned enough.

• Brand Name: ISOFLEX LAL,2860, W/MEDSURG
• Type of Device: BED, FLOTATION THERAPY, 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: 7406247
• MDR Text Key: 104659853
• Report Number: 0001831750-2018-00195
• Device Sequence Number: 1
• Product Code: IOQ
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2018

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
• Device Operator: No Information
• Device Catalogue Number: 2860000997
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/09/2018
• 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