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

Model Number P7500A000578

Device Problem Break (1069)

Patient Problems Fall (1848); Hematoma (1884)

Event Date 09/25/2023

Event Type  malfunction  

Event Description

The customer alleged the intermediate siderail on the progressa bed broke and a patient fell to the floor.It was unknown if the patient was injured at the time of the initial call.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The customer alleged the intermediate siderail on the progressa bed broke and a patient fell to the floor.It was unknown if the patient was injured at the time of the initial call.The following additional information was obtained from the customer.The bed was in its lowest position and the patient who weighed 330 lb was leaning on the siderail when it broke.Nursing staff indicated the siderail was properly locked in the upright position prior to the incident.The patient reportedly sustained a bump on the head.No medical intervention or treatment was required.The progressa bed is intended to be used to treat or prevent pulmonary or other complications associated with immobility, pressure ulcers, or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The instructions for use (ifu) states siderails are intended to be a reminder to the patient of the bed¿s edges, not a patient-restraining device.When appropriate, hill-rom recommends that medical personnel determine the proper methods necessary to make sure a patient remains safely in bed.Siderails in the raised position are intended to make the patient aware of the proximity of the edge of the sleep surface.A field investigation was performed by the baxter service technician and the left intermediate side rail was noted to be damaged.Two screws on the side rail were found on the floor by nursing staff.One screw broke the metal piece it was connected to.Additionally, the baxter service technician spoke with the nursing staff regarding the patient fall.The bed exit was set and was going off all day.A sitter was requested, but not provided.After the fall, a bump formed on the patient¿s head later in the day and the patient stated, ¿he was good.¿ a ct scan was negative.No additional information provided.The customer indicated the bed would be repaired by a third-party vendor.In this event, the patient sustained a bump on the head, which may have presented as a hematoma.A hematoma is an injury to tissues, without breakage of skin, in which blood from the broken vessels accumulates in surrounding tissues, which may produce pain, swelling, and tenderness.Most hematomas heal without treatment, but cold compresses may reduce bleeding if applied immediately after the injury, and thus may reduce swelling, discoloration, and pain.There was no indication the event was life threatening, ct scan was negative, and there was no report of medical intervention required to preclude permanent impairment of body function or permanent damage to body structure, which concludes a serious injury did not occur.The ultimate cause of the event is undetermined but possibly related to the patient leaning on the siderail.If the reported problem (broken siderail) were to recur, it would be likely to cause or contribute to a death or serious injury.

• 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: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17976191
• MDR Text Key: 326161283
• Report Number: 1824206-2023-01186
• Device Sequence Number: 1
• Product Code: FNL
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P7500A000578
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2023
• 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