MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOTOUR, 84 INCH,STD, END406; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 2872000012

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

Patient Problem Pressure Sores (2326)

Event Date 07/14/2022

Event Type  Injury  

Event Description

It was reported that the customer has had patients experience hospital acquired pressure injuries in the departments where they utilize the isotour standard mattresses.Further information has not been provided.

Manufacturer Narrative

The customer communicated that they did not document any serial numbers of the units the alleged issue occurred on.The customer stated that they believed the pressure injuries were located on either the sacral region or the heel.However, this could not be confirmed as the customer did not document this.Additionally, it was communicated that the customer did not complete a root cause analysis or investigate the alleged issue themselves and is not able to provide any further information.Based on the information provided by the customer, it could not be confirmed that the product caused or contributed to the alleged issue.Additionally, there are many factors that contribute to pressure ulcer development including heat, moisture, pressure braden scale ratings, patient mobility, nursing monitoring, and rotation schedules.This issue was resolved for the customer by providing additional training on utilizing the support surface and confirming that no further action was required regarding this alleged issue.H3 other text : actual device not identified.

Event Description

It was reported that the customer has had patients experience hospital acquired pressure injuries in the departments where they utilize the isotour standard mattresses.

• Brand Name: ISOTOUR, 84 INCH,STD, END406
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 15203501
• MDR Text Key: 297671444
• Report Number: 0001831750-2022-00899
• Device Sequence Number: 1
• Product Code: IKY
• 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,Followup
• Report Date: 12/09/2022

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 Catalogue Number: 2872000012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 07/14/2022
• Supplement Dates FDA Received: 12/09/2022
• 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
• Patient Outcome(s): Other