MAUDE Adverse Event Report: HILL-ROM BATESVILLE NP100 80X35.5X6 MRS; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number P100A4

Device Problem Material Separation (1562)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/16/2016

Event Type  Injury  

Manufacturer Narrative

The hill-rom technician evaluated the mattress and found the side bolster foam was no longer adhered to the slotted foam in the seat section on the patient left side of the mattress.The mattress was discarded after evaluation and a new mattress was sent as replacement.The np100 mattress is manufactured by tridien for hill-rom.Upon investigation, it was found that the delamination of the foam mattress core led to the collapse of the mattress.The foam gluing process was reviewed as well as the foam supplier.A new foam supplier was approved and the foam core assembly process has now been moved from tridien to the new supplier.Tridien has updated the their build of materials to assemble the mattress with foam cores produced by the new supplier.The account reported that the patient sat up on the side of the bed to reach for a glass of water on the bed side table when he fell.He was found with his back against the bed.The account did not provide what tests or treatments were performed on the patient, only stating that he fractured his right leg at the hip.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating a patient fell and broke their right leg near the hip.The mattress was located in room m06 at the facility.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: NP100 80X35.5X6 MRS
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 6178270
• MDR Text Key: 62537885
• Report Number: 1824206-2016-00530
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 11/16/2016

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?: No
• Device Operator: Other Caregivers
• Device Model Number: P100A4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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: 80 YR
• Patient Weight: 104