MAUDE Adverse Event Report: HILL-ROM BATESVILLE ACCUMAX CONV PREM; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number P0910-05459

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

The hill-rom technician found the blower was alerting for low pressure.The technician advised the patient's family to replace the blower.The patient's wound worsened to a stage 4.The wound was being treated with silvadene cream, but doctor recently ordered a wound vac and in-home care 3 times per week.Stage 3, 4 and unstageable meet the fda definition of serious injury as they necessitate medical or surgical intervention to preclude permanent damage to a body structure.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the patient's wound had worsened to a stage 4.The bed was located at the patient's home.There was a patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: ACCUMAX CONV PREM
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: erin padgett ; 1069 state route 46 east; batesville, IN 47006 ; 8129312791
• MDR Report Key: 7577884
• MDR Text Key: 110350805
• Report Number: 1824206-2018-00222
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: P0910-05459
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 40 YR
• Patient Weight: 34