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
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 or Problem 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
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 10896234
• Report Number: 0001831750-2020-01212
• Device Sequence Number: 14274049
• Product Code: FNM
• UDI-Device Identifier: 07613327504002
• UDI-Public: 07613327504002
• Combination Product (Y/N): N
• 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): 12/28/2020

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: 12/28/2020
• 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