MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOAIR PUMP; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number	2941
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient sustained a stage 4 pressure injury on an isoair support surface.Attempts are being made to gather more details from the user facility.
Additional Manufacturer Narrative
This supplemental is being filed to correct the model number and serial number of the device.
Event or Problem Description
It was reported that a patient sustained a stage 4 pressure injury on an isoair support surface.Attempts are being made to gather more details from the user facility.
Additional Manufacturer Narrative
A stryker staff design engineer evaluate the unit, where he found that the deflated central air bladders were due to kinking of the side bolster pressure sensor tube.The pump was returned to stryker and further evaluated, where it was determined that the pump properly prompted the disconnect air hose alarm.The patient sustained a stage 4 pressure injury on the surface, however, the patient was designated as high risk for a pressure injury.
Event or Problem Description
It was reported that a patient sustained a stage 4 pressure injury on an isoair support surface.

• Brand Name: ISOAIR PUMP
• Common Device Name: 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: marleca lane ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13826147
• Report Number: 0001831750-2022-00267
• Device Sequence Number: 4467259
• Product Code: FNM
• UDI-Device Identifier: 07613327503999
• UDI-Public: 07613327503999
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2023

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?: Yes
• Device Model Number: 2941
• Device Catalogue Number: 2941001001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 03/15/2022; 03/15/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 03/24/2022; 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown