MAUDE Adverse Event Report: HILL-ROM BATESVILLE PROGRESSA FRAME; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number P7500A000131

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 08/29/2016

Event Type  Injury  

Manufacturer Narrative

The account did not provide a specific bed or allege any malfunction.No further information is available on the bed at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.The (b)(6) old male patient had a preexisting dti on his sacrum found on (b)(6) that was 6x9 cm and.2 cm deep.This dti progressed to a stage 3 wound on (b)(6).The wound was treated with aquacel and mepilex dressings.The patient was admitted to inpatient care from (b)(6) with non-hodgkin's lymphoma.The patient was transferred between the medsurge department and icu several times due to his worsening underlying pathology.The 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 positions need to minimize the risk of pressure on vulnerable areas.

Event Description

Hill-rom received a report from the account stating the patient developed a dti that progressed to a stage 3 wound.The bed was located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: PROGRESSA FRAME
• 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: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 6004361
• MDR Text Key: 56789708
• Report Number: 1824206-2016-00436
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/06/2016

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: P7500A000131
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 10/06/2016
• 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 Age: 73 YR