MAUDE Adverse Event Report: N/A N/A

Model Number N/A

Device Problems Collapse (1099); Material Integrity Problem (2978)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Event Description

Over the past year or so, the customer's end-user had purchased about 40 transfer benches.They are now experiencing several leg failures.The problem is with the sleeve that the leg fits into - the sleeve cracks under load (weight), and the leg having no top support results in it collapsing.All the users in each case were reported as being well-below the load capacity of 400 lbs.From (b)(6) 2016 to date, there have been 3 each that have failed.Customer called in on behalf of end-user he had sold 40 transfer benches to - per the end-user, he has had 3 returned where the legs have collapsed and the user is within the weight limit.They were purchased about a year ago, and sold.On (b)(6) 2016 one user had received a small laceration on their forehead, but did not require treatment.The user that fell is reported as doing fine, and has had no issues since the fall - there will be no further treatment required for this incident.

Event Description

Device was returned to compass health brands on 10/20/2016, and inspected on 10/21/2016.Upon inspection, the item was found to be used with normal wear.The customer stated that the sleeve cracks under load and the leg having no top support collapses.The unit was assembled/tested, and found that the plastic sleeve (as stated) has cracked where the plastic leg is inserted.As a result the leg may not be able to support the appropriate weight, and could bent/tilt.The plastic may be to thin, or the material is not strong enough to support the weight.

• Brand Name: N/A
• Type of Device: N/A
• Manufacturer (Section G): N/A; n/a; n/a; n/a, n/a B3B 1 M2; CA B3B 1M2
• Manufacturer Contact: n/a n/a ; n/a; n/a; n/a, OH 44130 ; 8009471728
• MDR Report Key: 5944049
• MDR Text Key: 54501265
• Report Number: 9681423-2016-00011
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2016

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: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 77