MAUDE Adverse Event Report: EAGLE HEALTH SOLUTIONS SLIDING TRANSFER BENCH- SWIVEL SEAT

Model Number 290000

Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2015

Event Type  malfunction  

Event Description

While a female customer was in the bathtub sitting on a snap and save extra long sliding transfer bench, it broke at the swivel connection point.It was found that the swivel connection point between the seat and the sliding portion on the bench had broken.

Manufacturer Narrative

Manufacturer, eagle health solutions, was contacted on may 21, 2015 informing them of the incident and that prism medical would be reporting it to the fda.To date, this is our first recorded complaint on pn 290000.We will continue to monitor for this type of complaint information to evaluate if corrective actions are required of prism medical to address with eagle health solutions in the future.

Event Description

On (b)(6) 2015, a (b)(6) female customer was sitting on the sliding transfer bench (pn 290000) when it broke at the swivel connection point.The customer did not fall; she was unaffected.

• Brand Name: SLIDING TRANSFER BENCH- SWIVEL SEAT
• Type of Device: SLIDING TRANSFER BENCH- SWIVEL SEAT
• Manufacturer (Section D): EAGLE HEALTH SOLUTIONS; orange CA
• Manufacturer (Section G): PRISM MEDICAL; 10888 metro ct; maryland heights MO 63043 0000
• Manufacturer Contact: 10888 metro ct; maryland heights, MO 63043-0000
• MDR Report Key: 4814925
• MDR Text Key: 5831669
• Report Number: 3007802293-2015-00015
• 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: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/28/2015,09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 290000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/28/2015
• Distributor Facility Aware Date: 05/01/2015
• Event Location: Home
• Date Report to Manufacturer: 05/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 91