MAUDE Adverse Event Report: RIFTON EQUIPMENT BLUE WAVE BATH CHAIR

Model Number E543

Device Problems Crack (1135); Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  malfunction  

Event Description

It was reported that the bathchair base broke while in use.The user was caught by the caregiver and was not injured.

Manufacturer Narrative

Some of the broken surfaces showed discoloration, suggesting that cracks had been present for some time before any failure occurred.The cause of the cracking is not clear.The product manual warns: "inspect this product and accessories regularly for loose or missing screws, metal fatigue, cracks, broken welds, missing attachments, general instability or other signs of excessive wear.Immediately remove this product from use when any condition develops that might make operation unsafe.".

• Brand Name: BLUE WAVE BATH CHAIR
• Type of Device: BATH CHAIR
• Manufacturer (Section D): RIFTON EQUIPMENT; 100 spring valley road; farmington PA 15437
• Manufacturer (Section G): RIFTON EQUIPMENT; 100 spring valley road; farmington PA 15437
• Manufacturer Contact: travis scott ; 103 woodcrest drive; rifton, NY 12471 ; 8456587722
• MDR Report Key: 14642764
• MDR Text Key: 301824859
• Report Number: 3010761454-2022-00001
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: E543
• Device Catalogue Number: E543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2011
• 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 Age: 28 YR
• Patient Sex: Female
• Patient Weight: 49 KG