MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON HTS; TOILET CHAIR

Model Number Z130

Device Problems Device Slipped (1584); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Injury (2348); Deformity/ Disfigurement (2360); Tooth Fracture (2428)

Event Date 10/19/2015

Event Type  Injury  

Manufacturer Narrative

After conducting a preliminary analysis and in house tests on similar devices, we believe it would be very unlikely that the user would manage to undo a properly functioning seat belt just by turning and wriggling as was reported by the user facility.The investigation is ongoing, but because we have not yet received the seat belt back for analysis, we are unable to reach a full conclusion at this time.We are actively pursuing return of the seat belt.

Event Description

It was reported that the user was strapped into the toilet chair using the seat belt.The user allegedly loosened the seat belt by turning and wriggling, and was able to move forward in the chair.The carer was unable to catch him in time, and he hit his face against a tiled wall.The user has had up to three teeth removed and will need facial reconstruction.

Manufacturer Narrative

The seat belt was not returned for inspection, but analysis of pictures of the belt in question show that the device was made and assembled correctly and that the device was not broken.In house testing on similar devices shows a very low likelihood of the user undoing the seat belt by turning and wriggling as was reported.It is our conclusion that either the seatbelt was improperly tightened, or the client loosened it with his hand.Safe use of the rifton hts depends on the presence of an attentive and responsible caregiver.In this incident it is apparent that adult supervision was insufficient.The device may also not be appropriate for the client.The product manual states "this product is intended for use by clients of unreliable judgment.Adult supervision is required at all times." and "a qualified professional must assess the appropriateness and safety of all equipment for each user.".

• Brand Name: RIFTON HTS
• Type of Device: TOILET CHAIR
• Manufacturer (Section D): RIFTON EQUIPMENT; 2255 platte clove road; elka park NY 12427
• Manufacturer (Section G): RIFTON EQUIPMENT; 2255 platte clove road; elka park NY 12427
• Manufacturer Contact: travis scott ; 2032 rt 213; po box 903; rifton, NY 12471 ; 8456587722
• MDR Report Key: 5232417
• MDR Text Key: 31461916
• Report Number: 1319558-2015-00006
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: Z130
• Device Catalogue Number: Z130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2015
• 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): Required Intervention
• Patient Age: 16 YR