MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE NITRUM; WHEELCHAIR, MECHANICAL

Model Number QUICKIE NITRUM

Device Problem Compatibility Problem (2960)

Patient Problems Laceration(s) (1946); Post Traumatic Wound Infection (2447)

Event Date 09/10/2022

Event Type  Injury  

Manufacturer Narrative

Background information: quickie nitrum owner's manual, rev.B, page 4 states: "choose the right chair & safety options.Sunrise provides a choice of many wheelchair styles to meet your needs.This product is intended for single person use only.Final selection of the type of wheelchair, options and adjustments rests solely with you and your health care provider.Choosing the best chair for your unique mobility needs, will depend on such things as: 1.Your disability, grasping strength, balance and coordination.2.The types of hazards you must overcome in daily use (where you live and work, and other places you are likely to use your chair).3.The need for options that will improve your positioning, safety and comfort (such as anti-tip tubes, positioning belts, or special seating systems)." risk document ufmea_manual product_master 4.2.1.1.1 states: incorrect measurement and other metrological aspects- positioning incorrect / uncomfortable.Continuous rubbing- end-user not supported properly because chair was not spec'd out correctly; end-user not measured correctly.Discussion: in reviewing the complaint and speaking with the end user, she reports that she flips back the footplates and uses her feet to propel the chair when traveling throughout her home and in public.While propelling the chair, she hit the back of her ankle on the footrest bar and received a wound on the back of her right ankle.All footplates offered on the nitrum chair have a bar (round tube) assembled in the frame for attachment.The most probable root cause would be the wheelchair was not properly fitted to the end user to support their mobility needs.The end user stated that she believed she was sold the wrong wheelchair.She was unsure if she was fitted to the wheelchair properly and stated that she had to be retrofitted to the wheelchair for it to work for her.The way the wheelchair was measured has made it difficult for the end user to self-propel without repeated contact with the footplate bar.This repeated contact led to the alleged wound sustained on the back of the end user's ankle.According to the end user, 10 days after using the wheelchair, she received a wound on the back of her right ankle.She states that her medical conditions (neuropathy and diabetes) made it where she could not feel when the footplate bar would hit the back of her foot/ankle.When the wound was first discovered in september, it had become severely infected and lead to the end user needing to be hospitalized for 4 days with iv antibiotics administered.Once discharged, the end user required 4 months of wound care from an in home wound specialist.The wound healed but eventually opened back up after foot propelling in the quickie nitrum again.The end user is now currently using a previous chair.Conclusion: in conclusion, there was no fault found with the footplate assembly and the wheelchair was made to the product specification provided.The wheelchair was not properly measured for the end user's needs.Due to the allegation of a serious injury (severely infected wound) that required medical intervention (hospitalization and long term wound care), this mdr is being filed.

Event Description

The end user reports that while propelling in her wheelchair with her feet, she unknowingly hit the back of her right ankle on the footplate bar, leading to the development of a wound.The wound became severely infected, leading to hospitalization and 4 months of wound care.The wound healed but was subsequently opened after continuing to foot propel in the quickie nitrum rather than placing the feet on the footplates and using the handrim to move around.The end user is currently using a previous chair.

• Brand Name: QUICKIE NITRUM
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park avenue; fresno CA 93727 1328
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park avenue; fresno CA 93727 1328
• Manufacturer Contact: christian stephens ; 2842 n business park ave; fresno, CA 93727 ; 5592942374
• MDR Report Key: 16566567
• MDR Text Key: 311512765
• Report Number: 2937137-2023-00002
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00016958059397
• UDI-Public: (01)00016958059397(12)QNI-003616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QUICKIE NITRUM
• Device Catalogue Number: EIR12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 73 KG