MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TRANSPORT CHAIR,ALUM, BASIC,12" WHL,RED

Catalog Number MDS808210ARE

Device Problem Defective Component (2292)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

It was reported by the customer's daughter, that her father, transferred her mother, out of the car and into the transport chair which was sitting on the driveway.Customer stated that the driveway has a slight incline, however after her father put the brakes on the transport chair and turned around to get something else out of the car the breaks did not hold and the chair started to slip down the driveway.The father reportedly jumped toward the transport chair to grab the chair before it rolled down the driveway and he fell to the ground.The father was able to grab the bottom of the chair to prevent the chair from rolling, however he was not able to get back up from the ground without assistance from others.The father went to his personal care doctor for follow up and reportedly had x-rays performed at his personal care doctor's office.The customer reported that her father reportedly fractured an unknown number of ribs on his left side.The customer does not know how many ribs were fractured but stated there was no medical intervention required or other injury noted.The customer stated that there was no incident that occurred with her mother.The mother remained in the chair without incident or injury.The chair is available and has been requested to be returned for evaluation.Due to the reported incident of the customer's father experiencing fractured ribs and in an abundance of caution, this medwatch is being filed.No additional information is available.The device was not returned to the manufacturer for evaluation.The customer reported issue was not confirmed.No additional information is available.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

Reportedly, per the end user, the brakes on the transport chair were not locking, resulting in the customer falling and fracturing an unknown number of ribs.

Manufacturer Narrative

Corrected information: d10, h3, h6-the device was returned for evaluation on 2/11/2020 additional information-the sample evaluation was completed 3/06/2020 and found that upon further investigation of the sample it was discovered that the brakes seemed to be slightly out of adjustment.When the brake was set the rear wheel would continue to rotate.Based on the condition of the transport chair it is undetermined what type of maintenance has been performed.At this time the customer complaint in regards to the brakes on the transport chair not locking has been confirmed however a root cause has not been determined.No additional information is available.

• Type of Device: TRANSPORT CHAIR,ALUM, BASIC,12" WHL,RED
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 9716793
• MDR Text Key: 186542155
• Report Number: 1417592-2020-00008
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS808210ARE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 82