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

Model Number P642ACAP0000000

Device Problems Inflation Problem (1310); Pressure Problem (3012)

Patient Problem Pressure Sores (2326)

Event Date 11/21/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that a compella bed overinflated at the foot, leading to a ¿suspected deep tissue injury (sdti)¿ to the patient¿s right heel.Follow-up attempts were made with the customer, however, they have not provide any further details of the initial alleged harm/injury associated with the device, including: any pre-existing skin injuries noted prior to being placed on the device, medical intervention provided, delay, if the device provide any audible/visual messages/alerts prior to the event, amount of time the patient was on the device, mattress pressure mode, how often the patient was being turned, type of sheets being used utilized/ fit/ how tight/ number of bed linens under patient, additional devices being used to help manage pressure injuries, and additional patient information including admitting diagnoses, past medical history, gender, age and weight, and each patient¿s outcome.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).Inspection of the device by a hillrom technician is pending.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.Deep tissue pressure injuries (dtpi) are persistent non-blanchable deep red, purple or maroon areas of intact skin, non-intact skin or blood-filled blisters caused by damage to the underlying soft tissues.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 some cases, dti could resolve in few days, becoming pi stage 1 or 2 once they appear on the external layers of the skin.In other cases, they could develop into stage 3 or 4 (or unstageable) depending on the involvement of deeper underlying structure.In this event, due to the limited information provided on the patient¿s dti and pending inspection of the device, a critical/serious injury or malfunction cannot be excluded at this time.No further information is available on the repair of 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.

Event Description

It was reported that a compella bed overinflated at the foot, leading to a ¿suspected deep tissue injury (sdti)¿ to the patient¿s right heel.The bed was located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

Event Description

It was reported that a compella bed overinflated at the foot, leading to a ¿suspected deep tissue injury (sdti)¿ to the patient¿s right heel.The bed was located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

It was reported that a compella bed overinflated at the foot, leading to a ¿suspected deep tissue injury (sdti)¿ to the patient¿s right heel.Follow-up attempts were made with the customer, however, they have not provide any further details of the initial alleged harm/injury associated with the device, including: any pre-existing skin injuries noted prior to being placed on the device, medical intervention provided, delay, if the device provide any audible/visual messages/alerts prior to the event, amount of time the patient was on the device, mattress pressure mode, how often the patient was being turned, type of sheets being used utilized/ fit/ how tight/ number of bed linens under patient, additional devices being used to help manage pressure injuries, and additional patient information including admitting diagnoses, past medical history, gender, age and weight, and each patient¿s outcome.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.Deep tissue pressure injuries (dtpi) are persistent non-blanchable deep red, purple or maroon areas of intact skin, non-intact skin or blood-filled blisters caused by damage to the underlying soft tissues.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 some cases, dti could resolve in few days, becoming pi stage 1 or 2 once they appear on the external layers of the skin.In other cases, they could develop into stage 3 or 4 (or unstageable) depending on the involvement of deeper underlying structure.Inspection by a hillrom technician noted ¿all faulty mattress were replaced for the customer.¿ a malfunction was noted with the device.In this event, due to the limited information provided on the patient¿s dti, a critical/serious injury cannot be excluded at this time.Based on this information, no further action is required.

• 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: 15999305
• MDR Text Key: 305680805
• Report Number: 3006697241-2022-00091
• 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,Followup
• Report Date: 04/26/2023

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 04/26/2023
• 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 Outcome(s): Other