MAUDE Adverse Event Report: HILL-ROM BATESVILLE P500 MRS CONTROL UNIT; BED, FLOTATION THERAPY, POWERED

Model Number P005723CAP02

Device Problem Inflation Problem (1310)

Patient Problem Pressure Sores (2326)

Event Date 08/31/2018

Event Type  Injury  

Manufacturer Narrative

The account stated that the mattress was not inflating properly and the patient had a pre existing wound on his right ischium that was almost healed, but has now progressed into a stage 3 wound.The patient stated that he is receiving the same daily wound dressing changes, but more frequently due to the extra leakage.A stage 3 pressure ulcer meets the criteria for a serious injury per fda definition.Development of pressure ulcers is multi-factorial and cannot be only attributed to performance of the surface.Risk factors include protein-calorie malnutrition, micro-climate (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, re-positioning needs to avoid stress on the skin, and body positions need to minimize the risk of pressure on vulnerable areas.The hill-rom technician evaluated the mattress and blower and found the hose connections were clogged due to nicotine build up.He also found some of the hose connections were broken and unable to connect due to the damaged sustained from the account moving the unit from room to room.The blower unit was also showing a pneumatic error 3 due to the air loss.It is necessary for the p500 to have an effective maintenance program.We recommend that you do annual preventive maintenance.Examine the air filter for cleanliness.Clean or replace as necessary.Make sure the hose, hose connectors, hose receptacles, and end covers are not damaged (no kinks, cracks, holes, broken parts, etc.) replace or repair as necessary.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the patient stating his pre existing wound was almost healed and now it has gotten worse.The blower and mattress are located at the patients home.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: P500 MRS CONTROL UNIT
• Type of Device: BED, FLOTATION THERAPY, 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: 7905462
• MDR Text Key: 121583153
• Report Number: 1824206-2018-00372
• Device Sequence Number: 1
• Product Code: IOQ
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2018

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: P005723CAP02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• 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 Age: 34 YR
• Patient Weight: 91