MAUDE Adverse Event Report: HILL-ROM MEXICO COMPELLA AIR MATTRESS, RW, CPR; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number P642ACAP0000000

Device Problem Inflation Problem (1310)

Patient Problem Pressure Sores (2326)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that a compella bed overinflated at the foot, leading to an unstageable pressure injury to the patient¿s right posterior heel of approximately 3x3cm.No medical intervention or delay was alleged, however the patient had input from occupational therapy, podiatry, wound care, and dietician to assist with wound healing and offloading.Customer states nursing staff were turning patient 2-3 times hourly, 1 standard bed sheet was used under the patient, a heel wedge was used initially, and then they introduced heelift suspension boots for improved offloading.Patient is a 67-year-old male, weighting 142 kg, with a relevant medical history of, ¿poorly controlled¿ type 2 diabetes, chronic bilateral leg cellulitis, congestive cardiac failure, and asthma.Customer states the pressure injury has almost completely resolved.The compella bariatric bed system is intended to provide patient support in health care environments and may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (pacu), and sections of the emergency department (ed).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.Ulcers covered with slough or eschar are unstageable.Treatment can include frequent repositioning off the site of injury, good skin care, proper support surface selection, correcting any systemic issues or nutritional deficiencies and medical treatment from a wound care specialist.At times additional treatments can include prescribed antibiotic therapy and removal of dead tissue to promote healing and prevent or treat infection.In this event, due to the patient¿s unstageable pressure injury and pending inspection of the device, a critical/serious injury or malfunction cannot be excluded at this time.Inspection of the device by a hillrom technician found the last long bladder is bulging at the foot end and not deflating.Hillrom is replacing the air mattress.A malfunction was noted per the inspection.In this event, due to the patient¿s unstageable pressure injury, a critical/serious injury cannot be excluded at this time.Based on this information, no further action is required.

Event Description

It was reported that a compella bed overinflated at the foot, leading to an unstageable pressure injury to the patient¿s right posterior heel of approximately 3x3cm.No medical intervention or delay was alleged, however the patient had input from occupational therapy, podiatry, wound care, and dietician to assist with wound healing and offloading.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: COMPELLA AIR MATTRESS, RW, CPR
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 15963417
• MDR Text Key: 305334760
• Report Number: 3006697241-2022-00087
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/12/2022

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 Model Number: P642ACAP0000000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2022
• Initial Date FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2019
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 142 KG