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

Model Number P642ACAP0100000

Device Problem Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Date 01/25/2023

Event Type  Injury  

Manufacturer Narrative

The customer initially reported the compella ¿connecting tube¿ (that keeps the center section of the device inflated) easily becomes undone, leaving the patient lying on a flat mattress and alleged the patient had a pressure ulcer.Follow up with the customer confirmed the patient developed a deep tissue injury to both their sacrum and left buttocks due to using the device with hoses disconnected (deflated) and additionally stating the patient was not turned per customer policy.Medical intervention to both the sacrum and buttocks included: cleaning with normal saline, application of z guard and santyle to wound.The patient is a 45-year-old male, weighing approximately 300 pounds, admitted for acute respiratory failure and has a medical history of hepatic failure, encephalopathy, hypertension, coronary artery disease and heart failure.It is noted the patient currently remains at the hospital and has been moved from the icu to a step-down unit.Preventative maintenance (pm) search was performed on this serial number resulting in no pm records found for this serial number.The customer requested an inspection of the device.The facility director additionally states, ¿i was informed that the bed was not on max inflate and the hoses were disconnected.Staff continued to silence alarm.When interviewing staff, they could not recall the bed alarming.I was informed a baxter rep came to our hospital and did a quick inservice on the bed.These were the talking points provided to staff from the inservice: (1) ensure cpr valve is fully closed, (2) check for error 6 on siderail display.If present, this means the bed is not fully extended.Fully extend bed, (3) if neither 1 or 2 are present or bed continues to alarm or is not fully inflated: (a) call trimedx @ 2784, (b) report to the trimedx operator that you have bed alarm and need stat resolution, then provide a call back number.If you have the bed equipment id that will be helpful, (c) trimedx on call will return your call and attempt to resolve over the phone, (d) if trimedx is unable to immediately resolve, call evs at 2455 and request another bed asap.¿ 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).The device ifu notes the following on the air supply unit: (1) if the mattress is not inflating, an alarm will make the caregiver aware of the issue and the ifu provides guidance on troubleshooting, which mitigates the risk of a serious incident occurring from the malfunction.(2) if the cpr mechanism is not fully closed when the unit is in max inflate mode, an alert will sound to let you know of the air loss through the cpr valve.The device ifu additionally notes the following on fully extending/fully retracted position & err 6: if the bed does not reach the fully extended or fully retracted position, these will occur: both indicators next to the retract and extend controls will flash amber until the bed is fully extended or fully retracted.A continuous triple beep will sound until the bed is adjusted to the fully extended or fully retracted position.Err 6 will flash on the caregiver control pod until the bed is fully extended or fully retracted.Fully extend or fully retract bed width to clear the err 6 code and silence the triple beep.Once the bed is fully extended or retracted, the control¿s indicator will come on green and a single confirmation beep will sound.Inspection of the device by a hillrom technician found the account biomed had replaced the top cushion; however, had not inserted the 3/8 barb inserted all the way and additionally used the wrong zip tie causing the connector to come loose and therefore deflation of the device.Once the appropriate ties were resecured to the tube, the device was noted to be functioning as designed.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.For this event, two deep tissue injuries occurred requiring medical intervention of z guard and santyle to the wounds, indicating/unable to rule out that a serious injury occurred.It is noted that the device functioned as designed by alarming for mattress deflation; however, use error was likely involved as the hillrom technician states the account did not insert the 3/8 barb properly (all the way), and additionally used the wrong zip tie causing the connector to come loose and therefore deflation of the device.Additionally, the facility director reports staff silenced the alarm, kept the patient on a deflated device and did not abide by the facility turning policy.Based on this information, no further action is required.

Event Description

The customer initially reported the compella ¿connecting tube¿ (that keeps the center section of the device inflated) easily becomes undone, leaving the patient lying on a flat mattress and alleged the patient had a pressure ulcer.Follow up with the customer confirmed the patient developed a deep tissue injury to both their sacrum and left buttocks due to using the device with hoses disconnected (deflated) and additionally stating the patient was not turned per customer policy.Medical intervention to both the sacrum and buttocks included: cleaning with normal saline, application of z guard and santyle to wound.The bed was located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: COMPELLA AIR MATTRESS, NA
• 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: 16417361
• MDR Text Key: 309968580
• Report Number: 3006697241-2023-00014
• Device Sequence Number: 1
• Product Code: IKY
• UDI-Device Identifier: 00887761996779
• UDI-Public: 010088776199677911180205
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: P642ACAP0100000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2023
• 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 Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 136 KG