MAUDE Adverse Event Report: HILL-ROM, INC. VERSACARE BED; A/C POWERED ADJUSTABLE HOSP BED

Model Number 3200

Device Problem Material Integrity Problem (2978)

Patient Problems Wound Dehiscence (1154); Injury (2348)

Event Date 09/02/2014

Event Type  Injury  

Event Description

Hill-rom received a report from the account stating that the pt had a pre-existing stage four wound that was closed and now has reopened on the sacrum.The account also reported two new stage three wounds on the left and right ischia.The pt complained that the mattress was too hard.(b)(4).

Manufacturer Narrative

The hill-rom technician found error codes in the log but could not duplicate or find any issue with the bed.He tested the blower output and inspected the mattress and hose for tears, rips, and kinks and could not find any issues.He calibrated the air sys to clear the log and ease the pts concerns.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unk if the account performs preventative maintenance on their bed.The reported injury is serious in nature per fda definition.Development of pressure ulcers is multifactorial and cannot be only attributed to performance of the surface.Risk factors include protein-calorie malnutrition, microclimate (skin wetness caused by sweating or incontinence), diseases that reduce blood flow to the skin, such as arteriosclerosis, or diseases that reduce the sensation in the skin, such as paralysis or neuropathy.Position changes are key to pressure sore prevention and treatment.These changes need to be frequent, repositioning needs to avoid stress on the skin, and body positons need to minimize the risk of pressure on vulnerable areas.

• Brand Name: VERSACARE BED
• Type of Device: A/C POWERED ADJUSTABLE HOSP BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4176634
• MDR Text Key: 20453184
• Report Number: 1824206-2014-02352
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2014

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
• Device Model Number: 3200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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: 49