MAUDE Adverse Event Report: SAGE PRODUCTS LLC SAGE AIRTAP LC 5; PREVALON AIRTAP LC

Catalog Number	7287
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Involved device, photograph or lot number were not provided for evaluation.Therefore a visual inspection nor a review of phr could be completed.H3 other text : involved device discarded by facility.
Event or Problem Description
Report received of a strap that broke on the sage airtap lc device while it was being used to transfer a deceased patient to a cart in order to be transferred to the morgue.Although several attempts were made, company sales representative was unable to gain any additional information.No lot information, product or photographs were provided.

• Brand Name: SAGE AIRTAP LC 5
• 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: susie hinkle ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 15654240
• Report Number: 0001419181-2022-00008
• Device Sequence Number: 17739192
• Product Code: FSA
• UDI-Device Identifier: 50618029720806
• UDI-Public: 50618029720806
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 7287
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown