MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6257 XPEDITION HIGH CONFIG; TRANSPORT, PATIENT, POWERED

Catalog Number	625705550002
Medical Device Problem Codes	Protective Measures Problem (3015); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the chest belt was bent to the point where it could not be locked (inadequate patient restraint).No adverse consequence was alleged to have occurred as a result.
Event or Problem Description
It was initially reported that the chest belt was bent to the point where it could not be locked (inadequate patient restraint).Further communication with the customer identified that this was reported in error.The customer confirmed that there was no issue with the unit reported under the initial mdr.
Additional Manufacturer Narrative
Further communication with the customer identified that the complaint for this unit was submitted in error.The customer stated that there was no problem with the restraints.H3 other text : customer clarified that the alleged defect was reported in error.

• Brand Name: 6257 XPEDITION HIGH CONFIG
• Common Device Name: TRANSPORT, PATIENT, POWERED
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18087781
• Report Number: 0001831750-2023-01330
• Device Sequence Number: 6628742
• Product Code: ILK
• UDI-Device Identifier: 07613327581607
• UDI-Public: 07613327581607
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K222818
• 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): 02/27/2024

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
• Device Catalogue Number: 625705550002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 02/27/2024
• 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
• Patient Sex: Unknown