MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOTOUR, 84 INCH,STD, END406; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Catalog Number 2872000012

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported that a staff member was injured due to the weight of the isotour mattress during cleaning.Attempts are being made to gather additional injury and treatment details from the user facility.

Event Description

It was reported that a staff member was injured due to the weight of the isotour mattress during cleaning.It was further identified that the staff member submitted a wsib claim and was on modified duty.

Manufacturer Narrative

The device was not made available by the customer.

• Brand Name: ISOTOUR, 84 INCH,STD, END406
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18222451
• MDR Text Key: 329193067
• Report Number: 0001831750-2023-01349
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 07613327424638
• UDI-Public: 07613327424638
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 2872000012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2023
• 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