MAUDE Adverse Event Report: SAGE PRODUCTS LLC AIRTAP LC GS 10; PREVALON AIRTAP LC

Catalog Number	7289
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fall (1848)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Report received of a patient injury.Reporter stated a patient fell while the airtap lc device was in use.Reporter stated on approximately (b)(6) 2024 the device was being used for a transfer from the interventional radiology table to a transfer cart.Reporter stated the device was not being used with a lift but was inflated to assist in the transfer.Reporter stated the device inflated correctly and did not malfunction.Reporter stated the patient was centered on the device but off centered on the table and when the device was inflated the patient fell off the side of the table.The reporter stated there are no side rails on the bed.Staff were present on the side of the receiving surface; however, no staff were present on the side of the sending surface which was the side from which the patient fell.Reporter stated the fall resulted in an unspecified injury that required hospitalization.Additional information has been requested.
Event or Problem Description
Multiple attempts to obtain additional information were made.Although requested, no additional information was received.
Additional Manufacturer Narrative
The involved device, lot number, and photographs were not returned to aid in the investigation.Therefore, neither a visual/functional inspection, nor product history review could be performed.A labelling review was performed.The device instructions state "improper usage of the product can cause injury to the patient or healthcare provider.Operate the product only as described in this manual" and "always ensure the patient is centered on the glide sheet before inflating" and "always use more than one trained healthcare provider to laterally transfer, vertical lift transfer, or reposition a patient".The instructions were not followed in this instance, resulting in patient injury.The root cause of this issue is product misuse.

• Brand Name: AIRTAP LC GS 10
• Common Device Name: PREVALON AIRTAP LC
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• Manufacturer (Section G): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• Manufacturer Contact: maeve linder ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 21005310
• Report Number: 0001419181-2024-00017
• Device Sequence Number: 18604496
• Product Code: FSA
• UDI-Device Identifier: 50618029720851
• UDI-Public: 50618029720851
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: Health Professional
• Device Catalogue Number: 7289
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown