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

Model Number NITRUM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 08/27/2022

Event Type  Injury  

Manufacturer Narrative

Background information: quickie nitrum owner's manual, rev.B, page 12 states: "warning! anti-tip tubes can help keep your chair from tipping over backward in normal conditions.Sunrise medical recommends the use of anti-tip tubes: when locked in place (in the "down" position) anti-tip tubes should be between 1 1/2 to 2 inches off the ground.A.If set higher than 2 inches, they may not prevent a tip-over.B.If set lower than 1 1/2 inches, they may "hang up" on obstacles and cause a fall or tip over.If you have to climb or descend a curb, or overcome an obstacle it may be necessary to have an attendant make sure the anti-tip tubes are rotated up, and out of the way, so that the chair and rider do not get stuck and/or become unstable.If you fail to heed these warnings damage to your chair, a fall, tip-over or loss of control may occur and cause severe injury to the rider or others." discussion: in reviewing the complaint, the dealer reports that when the end user was trying to go over a doorway threshold, he tipped backwards and hit his head.When the incident was first reported on (b)(6) 2022, the dealer at the time stated the anti-tip wheel broke and that there was no injury.An updated report from that dealer also provided information from the end user's father, detailing that he noticed the anti-tip was dangling from the chair after the incident.The father believed the anti-tip became caught when the end user was going onto a wheelchair ramp, leading it to become broken.A different dealer from the individual who had initially called and the end user provided new information that was not previously reported (reported injury, doorway threshold).The most probable root cause could be that the end user did not head the warnings in the owner's manual in regards to the anti-tips.As mentioned in the owner's manual for the quickie nitrum, to overcome an obstacle, it may be necessary to have the anti-tip tubes rotated out of the way to prevent the anti-tips from becoming stuck or causing instability.The most probable scenario based on the information provided is that when the end user went through the doorway threshold, the anti-tips were in the down position, the anti-tips caught on the threshold, and while the wheelchair was tipping backwards, it put non typical loading onto the anti-tips, leading to a broken wheel, bent anti-tip arm and the receiver unable to perform as intended.The end user reports that the rearward fall allegedly led to bleeding on the brain.He reports that he went to the hospital and had a ct scan, which is where the reported brain bleed was found.The end user followed up with his neurologist who determined that additional follow up wasn't necessary.There is no additional information on the end user's alleged injury or if any supplemental treatments have been sought.Conclusion: due to the allegation of a serious injury (bleeding on the brain) that required medical intervention (emergency room visit, follow up with neurologist), this mdr is being filed.

Event Description

Dealer reports that when the end user was trying to go over a doorway threshold, he tipped backwards and hit his head, allegedly leading to bleeding on the brain.He was taken to the hospital and had a follow up with his neurologist, who determined additional follow ups weren't necessary.

• 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: 16109056
• MDR Text Key: 306777952
• Report Number: 2937137-2023-00001
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00016958059397
• UDI-Public: (01)00016958059397(12)QNH-000570
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NITRUM
• Device Catalogue Number: EIR12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 66 KG