MAUDE Adverse Event Report: HILL-ROM MEXICO FLAT DECK 36" WIDE WITH X-RAY; BED, FLOTATION THERAPY, POWERED

Model Number P7924A01

Device Problem Inflation Problem (1310)

Patient Problem Pressure Sores (2326)

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

The customer reported that the pro+ surface¿s foam is ¿deflating at the sacral area¿ and a patient developed a stage 3 pressure injury on the buttock, sacrum, and coccyx.This patient is a 65-year-old female admitted for hypoxemia and anoxia brain injury.Upon admission ((b)(6)2023), this patient was noted to have a ¿healed pressure injury¿ at the sacral and coccyx areas.The patient¿s pressure injuries were reported to have been noted on (b)(6)2024.The medical intervention for the reported pressure injuries included triad ointment, a sacral dressing, and the introduction of an ehob waffle mattress overlay (third party).The customer reported that upon the introduction of the mattress overlay, there was ¿significant improvement noted in the wound, and some resulted in closure¿ and that at the patient¿s discharge ((b)(6)2024), only the stage 3 sacral pressure injury remained.The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.The pro+ mattress is intended for use in healthcare environments and is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.The mattress supports patients weighing between 70 lb (32 kg) and 500 lb (227 kg).The pro+ mattress with advanced microclimate® technology (amt) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned.Additionally, the instructions for use (ifu) states the therapy surface is not a substitute for good nursing practices.Therapy modes should be used in conjunction with good assessment and protocol.Failure to follow good nursing practices may result in patient harm.As no serial number was provided for this bed, a search of the baxter maintenance records for any baxter performed preventative maintenance on this bed was unable to be completed.¿ it is unknown if the facility performs preventative maintenance on their beds.¿ the development of pressure injuries is multifactorial and cannot only be attributed to the performance of the surface or the pro+ surface.Pressure injuries can develop within 2-6 hours when capillaries supplying the skin and subcutaneous tissues are compressed, causing an obstruction in blood flow, which ultimately leads to tissue necrosis.Position changes are key to pressure injury 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.Prevention of pressure injuries involves a multidisciplinary approach including rapid identification of at-risk individuals such as those with diabetes, incontinence, impaired mobility, peripheral vascular disease, etc., and exercising a vigilant prevention protocol consisting of skincare, nutritional assessment reducing mechanical load, and utilizing support surfaces.In this event, the patient was reported to have a stage 3 pressure injuries (buttock, sacrum, and coccyx) in which the intervention included the application of a non-prescription hydrophilic ointment and the introduction of an accessory mattress overlay lead to the ¿significant improvement¿ and ¿closure¿ of two of the three reported injuries.A stage 3 pressure injury is categorized as full-thickness tissue loss.Subcutaneous fat may be visible, but bone, tendon or muscle are not exposed.In this event, the patient required medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, concluding a serious injury occurred in this case.Additionally, the stage 3 sacral injury is ongoing therefore permanent damage to a body structure cannot be excluded at this time.The ultimate cause of the reported event is undetermined.At the time of this evaluation, an inspection could not be performed as the customer has not identified the specific bed associated with this patient.Due to the ongoing investigation, at this time baxter is unable to rule out that the bed caused or contributed to the serious injury.Based on this information, no further action is required.¿ the complaint record will be reassessed upon receipt of additional information.H3 other text : customer has not identified specific sn.

Event Description

The customer reported that the pro+ surface¿s foam is ¿deflating at the sacral area¿ and a patient developed a stage 3 pressure injury on the buttock, sacrum, and coccyx.This patient is a 65-year-old female admitted for hypoxemia and anoxia brain injury.Upon admission ((b)(6)2023), this patient was noted to have a ¿healed pressure injury¿ at the sacral and coccyx areas.The patient¿s pressure injuries were reported to have been noted on (b)(6)2024.The medical intervention for the reported pressure injuries included triad ointment, a sacral dressing, and the introduction of an ehob waffle mattress overlay (third party).The customer reported that upon the introduction of the mattress overlay, there was ¿significant improvement noted in the wound, and some resulted in closure¿ and that at the patient¿s discharge ((b)(6)2024), only the stage 3 sacral pressure injury remained.The bed was located at the account.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: FLAT DECK 36" WIDE WITH X-RAY
• Type of Device: BED, FLOTATION THERAPY, 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: 18661582
• MDR Text Key: 334800900
• Report Number: 3006697241-2024-00008
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2024

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: P7924A01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 97 KG