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

Model Number	2941
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 10896345
• Report Number: 0001831750-2020-01213
• Device Sequence Number: 3284923
• Product Code: FNM
• UDI-Device Identifier: 07613327504002
• UDI-Public: 07613327504002
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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
• Operator of Device: No Information
• Device Model Number: 2941
• Device Catalogue Number: 2941000001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other