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

Model Number P7500A000539

Device Problem Inflation Problem (1310)

Patient Problem Pressure Sores (2326)

Event Date 06/15/2021

Event Type  Injury  

Manufacturer Narrative

The hillrom technician found no malfunction with the bed mattress.The patient's past medical history included preexisting stage 2 and stage 3 pressure injuries, bedbound (last three years), nonverbal, and is in late stages of als.She preferred hillrom for the evaluation.Her husband ended up spending 58 days in the hospital for bone biopsies of a progressed stage 4 pressure injury as a result of delayed assessment of the bed.The patient's wife (caretaker) had been working with the va requesting evaluation of the bed as of (b)(6) 2021 due to bed inflation not holding correctly.The customer reported refusal of third-party inspection of the device arranged by the va.Timeline of events: (b)(6) 2021: awareness of an online request was received from customer (va) to hillrom to evaluate and repair mattress & bed.No report of patient information at this time.(b)(6) 2021: estimation for cost of repairs sent to the customer (va).(b)(6) 2021: approval for repair waiting on insurance.(b)(6) 2021: customer (va) called for an update and stated at this time the patient¿s wounds were getting worse.Original estimate sent second time to customer (va).(b)(6) 2021: current status still showing waiting on approval from insurance for repair.(b)(6) 2021: customer insurance approved.Technician spoke to patient¿s spouse and is waiting on the mattress to come in from back order ¿ once received will call and set time to come out to home and replace.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.Further investigation from the customer, patient's wife, stated a hillrom technician did come to their home on (b)(6) 2021, to assess the bed.The inspection of the bed by a hillrom technician found that the bed's settings were set too low for the mattress to inflate, noting use error.The technician also noted that the mattress needs replacement.The technician in-serviced the customer about mattress settings.Customer stated she is aware that re-positioning of the patient is needed by someone in addition to the bed, however she heavily relies on the bed turn assist functionality to help with this.Customer also stated that hillrom support has been great, however the va has taken longer to help her in request of the bed evaluation leading to her husband¿s pressure injuries progressing.Hillrom is currently awaiting arrival of new mattress,(currently on backorder) for replacement of the patient's current bed.Stage 4 pressure injury is described as a full thickness tissue loss with exposed bone, tendon or muscle, medical or surgical intervention is usually required and therefore meets the definition of a serious injury.A stage 2 or stage 3 pressure injury that progresses to a stage 4 is considered a serious injury.Therefore, hillrom is erring on the side of caution and reporting this event due to the serious injury involved.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician will replace the progressa mattress due to age.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the patient ¿wounds getting worse¿ with progressa mattress not inflating properly and needing repairs.The location of the device was at the patient¿s home at the time of the reported events.No alarms were noted.There was patient injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• 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: harish vishwanathan ; 1069 state route 46 east; batesville, IN 47006 ; 3127289851
• MDR Report Key: 12373078
• MDR Text Key: 268702456
• Report Number: 1824206-2021-00442
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761000100
• UDI-Public: 010088776100010011180329
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P7500A000539
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2018
• 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