MAUDE Adverse Event Report: PRISM MEDICAL COMFORT RECLINE SPACER H/S- XL; COMFORT RECLINE SLING

Model Number 8E4230

Device Problems Break (1069); Torn Material (3024)

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

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

The pommel strap is an optional feature added to the sling.It is used to keep the legs separated.If it were not present, the sling could be used without affecting patient safety.The pommel pouch could become detached if: girth of leg is too large, the individual is not centered or the weight shifts during lifting, the individual is too heavy, the pommel strap has been attached to a hook on the carry bar, rather than being looped over the hip straps as shown above.Root cause: unable to establish definitive root cause of detachment for returned sling.Correction: replacement sling was sent to the customer.Corrective action: customer service contacted the customer to see if they had questions on the correct method of use for the comfort recline spacer sling and how to properly attach the pommel straps and pouch.They also reminded the customer there is an instructional video on the website that can be viewed.

Event Description

During lift, hip strap snapped causing a change in position.Patient was very close to bed, didn't fall out of sling.

• Brand Name: COMFORT RECLINE SPACER H/S- XL
• Type of Device: COMFORT RECLINE SLING
• Manufacturer (Section D): PRISM MEDICAL; 10888 metro court; maryland heights MO 63043
• Manufacturer (Section G): PRISM MEDICAL; 10888 metro court; maryland heights MO 63043
• Manufacturer Contact: steve kilburn ; 10888 metro court; maryland heights, MO 63043 ; 3142198614
• MDR Report Key: 6077668
• MDR Text Key: 59556591
• Report Number: 3007802293-2016-00079
• Device Sequence Number: 1
• Product Code: ILE
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8E4230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/07/2016
• Device Age: 21 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2015
• 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 Age: 77 YR
• Patient Weight: 181