MAUDE Adverse Event Report: MERITS HEALTH PRODUCTS, INC. POWER WHEELCHAIR; WHEELCHAIR, POWERED

Model Number P301 GEMINI

Device Problems Break (1069); Unstable (1667); Unintended Movement (3026); Noise, Audible (3273)

Patient Problem Discomfort (2330)

Event Date 07/01/2021

Event Type  Injury  

Event Description

Pt states that he began to feel his chair move side to side initially and that it also began to make a creaking noise.Pt reports that as time went on the movement got worse and it got to a point where the seat felt like it as going to break off.Reporter states it became increasingly uncomfortable to sit in the chair because it began to tilt over in one direction as if it was going to break.Pt states the chair felt unstable and eventually he enlisted his neighbor¿s help to investigate the chair by releasing a mechanism that lifted the seat from the chair.Pt reports that the shaft that goes into the chair has broken away from the seat frame.Pt states that his 1 year warranty expired in 06/2021 so he went online to look for a replacement part.Pt notes that during his search he came across a recall notice for the part in question which included the model number of his unit.Pt reports that he spoke with the mfr and informed them of his issue but was told that his device was not included in the recall due the serial number of his unit not being listed.Pt reports that he called back after looking at the recall notice and inquired why his unit was not included in the recall despite having the same issue and alleges that the mfr said they could not further help him.Pt states that he contacted the fda about the device recall and was provided a link for online reporting but after receiving an error message, he was not able to complete the report.Pt notes that after emailing the fda again he was provided the number to make a phone report.Of note, pt states that he also submitted a report via the mfr¿s website and alleges he was contacted by a customer sales rep who informed him that the device was not apart of the recall and provided the information of the parts supplier.Pt believes that his device should be included in the recall.

• Brand Name: POWER WHEELCHAIR
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): MERITS HEALTH PRODUCTS, INC.
• MDR Report Key: 12869423
• MDR Text Key: 281321606
• Report Number: MW5105570
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/23/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: P301 GEMINI
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2021
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male