MAUDE Adverse Event Report: HILL-ROM BATESVILLE PROGRESSA FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P7500A001239

Device Problems Pressure Problem (3012); Appropriate Term/Code Not Available (3191)

Patient Problems Pressure Sores (2326); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported an increase in bedsores with use of the progressa beds.Per the customer, not enough training was provided to the staff on correct usage of the beds and some device functionality has not been used.Specific details of the bedsores including stage and location, if the pressure sores were preexisting, medical intervention, past medical history, accessory devices utilized, and facilities positioning protocols were not provided.Additionally, the customer did not associate a patient with a specific bed serial number.This evaluation addresses complaint 4 of 5.The progressa bed is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The progressa bed is intended to provide a patient support to be used in health care environments.The progressa bed 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 progressa bed is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.Instructions for use state ¿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.¿ 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.Attempts to obtain additional details to determine severity of the event including injury, medical intervention provided (if any), and patient outcome have been unsuccessful.Additionally, the device is pending inspection.If additional relevant information is received, the complaint will be reassessed, and the injury will be categorized accordingly.Based on the limited details available and the potential for serious injury, hillrom considers this complaint reportable.No further information is available on the repair of the bed at this time.If any additional relevant information is identified following completion of the repair, the additional relevant information will be submitted in a supplemental report.

Event Description

The customer reported an increase in bedsores with use of the progressa beds.Per the customer, not enough training was provided to the staff on correct usage of the beds and some device functionality has not been used.Specific details of the bedsores including stage and location, if the pressure sores were preexisting, medical intervention, past medical history, accessory devices utilized, and facilities positioning protocols were not provided.Additionally, the customer did not associate a patient with a specific bed serial number.This evaluation addresses complaint 4 of 5.The bed was located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

Event Description

The customer reported an increase in bedsores with use of the progressa beds.Per the customer, not enough training was provided to the staff on correct usage of the beds and some device functionality has not been used.Specific details of the bedsores including stage and location, if the pressure sores were preexisting, medical intervention, past medical history, accessory devices utilized, and facilities positioning protocols were not provided.Additionally, the customer did not associate a patient with a specific bed serial number.This evaluation addresses complaint 4 of 5.The bed was located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The customer reported an increase in bedsores with use of the progressa beds.Per the customer, not enough training was provided to the staff on correct usage of the beds and some device functionality has not been used.Specific details of the bedsores including stage and location, if the pressure sores were preexisting, medical intervention, past medical history, accessory devices utilized, and facilities positioning protocols were not provided.Additionally, the customer did not associate a patient with a specific bed serial number.This evaluation addresses complaint 4 of 5.The customer has provided the serial numbers of all 5 beds, but cannot attribute a patient or injury to a specific serial number at this time, therefore further information and investigation of the individual beds due to the covid patients has not yet been possible and is still ongoing.This report is for the bed with the serial number (b)(6).The progressa bed is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The progressa bed is intended to provide a patient support to be used in health care environments.The progressa bed 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 progressa bed is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.Instructions for use state ¿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.¿ 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.9/8/2022, clinical update there was no allegation of a device malfunction.Multiple attempts were made to obtain specific details of the event including categorization/staging of the reported pressure injury, clarification if the associated patient¿s pressure injury was preexisting, the medical treatment provided for the pressure injury, patient¿s medical history, accessory devices utilized, and facilities positioning protocols however, no additional could be obtained from the customer.The customer has not provided evidence that a serious injury has occurred and we can reasonably conclude that there is no malfunction as none have been reported by the customer and the beds were reported to have remained in use; therefore hillrom does not deem this a reportable event.Additionally, it is noted that hillrom/baxter representatives have not received any additional complaints of increased pressure injuries or any other malfunction from the customer.Initially the customer did not report any serious injuries, and multiple attempts were completed but the customer did not provide the necessary information to determine the severity of the injury.Based on the limited details provided, there is no indication that the reported pressure injuries were serious injuries or any indication of malfunction.If any additional relevant information is received, the event will be categorized accordingly.This event is not reportable.Based on this information, no further action is required.

• Brand Name: PROGRESSA FRAME
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 13973628
• MDR Text Key: 290943573
• Report Number: 1824206-2022-00165
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761000100
• UDI-Public: 010088776100010011210304
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: P7500A001239
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2020
• 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