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Model Number P7500A001603 |
Device Problems
Pressure Problem (3012); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pressure Sores (2326); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 5 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.
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Event Description
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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 5 of 5.The bed was located at the account.This report was filed in our complaint handling system as complaint #: (b)(4).
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Event Description
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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 5 of 5.The bed was located at the account.This report was filed in our complaint handling system as complaint # (b)(4).
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Manufacturer Narrative
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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 5 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 w020aw7549 where it was confirmed that there was no malfunction occurred.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.An inspection of the bed by a hillrom technician found the bed and its components to be working as designed.The inspection included general observations and software diagnosis.The bed was found without any failures.A retrieve of data of the progressa bed showed no error codes as measurements were always within specified ranges.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.
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