MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE Q700M; POWER WHEELCHAIR

Model Number Q700M

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 11/22/2022

Event Type  Injury  

Event Description

Dealer reports that the end user fell and allegedly "cracked" her ribs (presumably meaning some degree of bone break).There are limited details on the incident and the reported injury in general.There is no information on the extent of the injury or if medical treatment was received.

Manufacturer Narrative

Discussion: in reviewing the complaint, the dealer reports that the end user fell and "cracked" their ribs.There are no details on how the end user fell, the severity or number of the cracked ribs, the degree of any bone break, and whether the end user received medical treatment.The dealer assumes that the end user visited the hospital or emergency room due to the alleged injury, but she does not know for sure.The dealer mentioned with respect to the end user's power wheelchair that the power center mount has elevated the leg area and is not currently able to be brought down.She states that at this time, she is not sure if the user's fall was related to the leg area of the wheelchair being elevated.There are limited details on the incident and the alleged injury in general.Conclusion: while there is limited information on the incident, due to the allegation of a serious injury (cracked ribs presumably meaning a bone break), this mdr is being filed.Should new information be received, a supplemental report will be filed.

• Brand Name: QUICKIE Q700M
• Type of Device: POWER WHEELCHAIR
• 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: 16039018
• MDR Text Key: 306063957
• Report Number: 2937137-2022-00015
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172384
• 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: 12/22/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: Q700M
• Device Catalogue Number: EIPW25
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2018
• 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): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 44 KG