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

Section b5 has been updated to reflect additional information provided by the user facility.The user facility was not able to make the device available for evaluation and stated that the pressure injury was a result of use error, section h codes have been updated to reflect this.

Event Description

It was reported a patient developed a bed sore from a stryker mattress.Upon further investigation it was found that the user facility disconnected the air flow to the mattress, which caused the surface to completely deflate.The patient was not able to be moved to a different surface and developed a bed sore.

• 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: 10896345
• MDR Text Key: 218016674
• Report Number: 0001831750-2020-01213
• 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: 01/12/2021

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