MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOAIR 84" END406 US/CAN PUMP; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 2941

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pressure Sores (2326)

Event Date 10/19/2020

Event Type  Injury  

Event Description

It was reported a patient developed a bed sore from a stryker mattress.No information has been provided regarding the severity or treatment of the bed sores.Attempts have been made to reach the customer for more information; however, the customer has not responded to these attempts.

Manufacturer Narrative

Upon further investigation it was found that the user facility did not have a record of this injury and were unable to provide further details.Section b5 has been updated to reflect this.H3 other text : user facility stated there was no further action needed.

Event Description

A nurse, whose name was not recorded, reported that a patient suffered a pressure injury to their heel while on a stryker mattress; however, upon consultation with both the risk manager as well as the lead wound care nurse, the hospital had no report of this pressure injury.

• Brand Name: ISOAIR 84" END406 US/CAN PUMP
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 10896234
• MDR Text Key: 218013170
• Report Number: 0001831750-2020-01212
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 07613327504002
• UDI-Public: 07613327504002
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2941
• Device Catalogue Number: 2941000001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other