MAUDE Adverse Event Report: DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. VERANDA 18 IN X 16 IN FRAME W/FULL LENGTH PERM ARMS AND FOOTRESTS; MECHANICAL WHEELCHAIR

Model Number V18RLR

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384); Unintended Movement (3026)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

S/n (b)(4), lot 3016113-624, ship out on 09/24/2014.Check the inventory in warehouse and from customer side, no stock found; check dhr of this lot production, no this nonconformity record; wheelchair veering to left, due to front caster lack of maintenance, contribute to front caster not swivel freeely; alleged footrest is loose.Due to screw on support tube coming loose; update wi, specify 100% self check for operators; update sip,specifed inspection items; training qc and operators with updated sop.

Event Description

The chair is veering to the left and the footrest is loose.

• Brand Name: VERANDA 18 IN X 16 IN FRAME W/FULL LENGTH PERM ARMS AND FOOTRESTS
• Type of Device: MECHANICAL WHEELCHAIR
• Manufacturer (Section D): DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.; 36 danyan rd.; danyang, jiangsu 21230 0; CH 212300
• Manufacturer (Section G): DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.; 36 danyan rd.; danyang, jiangsu 21230 0; CH 212300
• Manufacturer Contact: yao wenbin ; 36 danyan rd.; danyang, jiangsu 21230-0 ; CH 212300 ; 5118619700
• MDR Report Key: 6019655
• MDR Text Key: 57621837
• Report Number: 3004766495-2016-00004
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: V18RLR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR