MAUDE Adverse Event Report: HILL-ROM BATESVILLE P500 THERAPY SURFACE; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P005723CAP01S

Device Problem Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Date 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

The patient alleged one side of a p500 mattress was deflating, ballooning at the foot section, putting pressure on and creating ¿sores¿ to his bilateral leg stumps, buttocks, and penis.Follow up with the patient stated because of this malfunction he now has new pressure injuries (pis).Current staging and location of the pis included, ¿stages 2 or 3 on bilateral leg stumps, stage 4 on buttocks, and stage 2 or 3 on penis.¿ medical intervention has involved surgeries and pi cleaning provided per home care nursing.He states his pcp is aware of the alleged device malfunction, pis and they are currently assessing finding him another bed type for home use.The patient notes he has had the p500 since 2014 and 3-5 years ago the device started to malfunction with the end of the bed blowing up or ballooning at the foot and leaning to the right.He conveyed he has used a ¿rachet¿ at times to hold the device down.The patient is a 46-year-old male weighing 150 pounds who has been paralyzed for 23 years, c-5 quadriplegic.He states over several years he has had pis intermittently with multiple surgeries.The patient requested a home inspection of the device.The p500 surface is for household and healthcare facility use.The surface is designed for use on pan-deck frames that accommodate this surface size; it is not intended for use on spring-deck frames.The intended users of this product are healthcare employees, non-clinical caregivers, and occupants who have the physical strength and cognitive skills to operate and control the product.Follow safety protocols if an intended user does not have the physical strength or cognitive skills to operate and control the product safely.The device ifu notes the following warning to reduce the risk of injury: use this product only for its intended use as described in this manual.Do not use attachments not recommended by the manufacturer.The device ifu additionally states the following warnings on the surface features & use: the surface is not a substitute for good nursing practices.The surface should be used in conjunction with a good risk assessment and protocol.Inspection of the device by a hillrom technician found a ¿ratchet strap¿ on the mattress.The technician advised the patient to remove the component, ¿to which he claimed it helped bring him relief.¿ the technician persisted with telling him it was doing the opposite, causing an air bubble that would likely cause irritation to his sites.The device was noted to be functioning as designed.The technician documented the patient refused to remove the strap prior to leaving the residence.Per hillrom principal engineer, based on the information provided by the technician above, the patient was using an incorrect attachment for the device.Use of a ratchet strap is not recommended by hillrom, as when applied around the foot section of the mattress it would likely result in slight deflating/ballooning depending on how tightly the strap was attached.In addition to the deflating/ballooning, the ratchet strap alone can directly apply sheer/pressure on the foot and could have likely resulted in the pressure injury.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.A stage 3 pressure injury is defined as full thickness tissue loss.Subcutaneous fat may be visible, but the bone, tendon or muscle are not exposed.Treatment may include prescribed antibiotic therapy and at times removal of any dead tissue to help promote healing and prevent or treat infection.A stage 4 pressure injury involves full thickness skin and tissue loss with exposed or directly palpable fascia, slough, muscle, tendon, ligament, cartilage, or bone in the ulcer.Treatment of stage iv pressure ulcers begin with the removal of dead tissue.If the damage is extensive, surgery is usually required.In this event, the reported stage 3 or 4 pressure injury required medical and surgical intervention (surgeries and pressure injury ¿cleaning¿) to preclude permanent impairment of a body function or permanent damage to a body structure, therefore meets the definition of a serious injury.During inspection it was reported that the bed system was functioning as designed.However, the technician noted the customer used attachments not recommended by the manufacturer (ratchet strap) on the p500 device, indicating use error.Prevention of this type of event are outlined per the ifu as noted above.Based on this information, no further action is required.

Event Description

The patient alleged one side of a p500 mattress was deflating, ballooning at the foot section, putting pressure on and creating ¿sores¿ to his bilateral leg stumps, buttocks, and penis.Follow up with the patient stated because of this malfunction he now has new pressure injuries (pis).Current staging and location of the pis included, ¿stages 2 or 3 on bilateral leg stumps, stage 4 on buttocks, and stage 2 or 3 on penis.¿ medical intervention has involved surgeries and pi cleaning provided per home care nursing.He states his pcp is aware of the alleged device malfunction, pis and they are currently assessing finding him another bed type for home use.The patient notes he has had the p500 since 2014 and 3-5 years ago the device started to malfunction with the end of the bed blowing up or ballooning at the foot and leaning to the right.He conveyed he has used a ¿rachet¿ at times to hold the device down.The patient is a 46-year-old male weighing 150 pounds who has been paralyzed for 23 years, c-5 quadriplegic.He states over several years he has had pis intermittently with multiple surgeries.The bed was located at the patient's home.The patient requested a home inspection of the device.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: P500 THERAPY SURFACE
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15784104
• MDR Text Key: 307804626
• Report Number: 1824206-2022-00496
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: P005723CAP01S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 68 KG