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

Model Number P3200K000500

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 01/03/2023

Event Type  Injury  

Manufacturer Narrative

The customer reported that a patient fall occurred resulting in ¿significant injury.¿ the customer did not provide details of the injury; however, the patient was described as a ¿bigger man, had been in the icu previously for (she believed) a stroke, and had also fallen earlier that day.¿ it could not be confirmed that the bed was a hillrom device, and no serial/model number was provided.The customer stated, ¿possibly a patient weight was not taken prior to arming the bed exit¿ and the device ¿did not sound.¿ per follow up from the customer director of patient services, ¿based on our investigation, there is no indication at this point that the bed functioning caused or contributed to the event.We were reaching out to make sure we were not missing something with the function/activation of the alarm and to see if you could assist with further education for our staff.We did not file a complaint.No patient information will be provided at this time.¿ multiple follow-up attempts were made with the customer; however, they have not provided any further details of the initial alleged harm/injury associated with the device, including injury details, chain of events, date of injury, medical intervention provided, length of delay allegations, device serial number, and additional patient information including admitting diagnoses, past medical history, age and weight, and the patient¿s outcome.Additional questions to the customer included: if any malfunction of the device was alleged, if any use error (not entering patients' weight prior to arming the device) was confirmed, and status of the device (still in use, pending inspection, etc.).The device is equipped with safety indicators that provide the caregiver with visual and audio indications of potentially hazardous conditions with the intention that the caregiver will respond to the alert and take appropriate action to rectify the issue.The device ifu states the following on the bed exit alarm system: (1) bed exit alarm system is not intended as a substitute for good nursing practices.The bed exit alarm system must be used in conjunction with a sound risk assessment and protocol.(2) the bed exit alarm system has three modes: patient position, bed exiting, and out-of-bed.(3) the bed exit alarm system must be zeroed before putting the patient on the bed.Also, if all three bed exit mode indicators are flashing, zero the bed exit alarm system.The device ifu states the following on out-of-bed mode alarms and the patient¿s weight: the out-of-bed mode alarms when the patient's weight shifts significantly off the frame of the bed.This mode should be used when a caregiver wants the patient to move freely within the bed, but to be alerted when the patient leaves the bed.Inspection could not be performed as the customer did not provide appropriate identification for the device (serial/model number).Hillrom senior clinical manager plans to follow up with the customer regarding the education requested.For this event, inspection is unable to be performed due to reasons above, however, it can be reasonably concluded that there was no malfunction with the device as the customer reported they ¿did not file a complaint¿ and stated, ¿no indication at this point that the bed functioning caused or contributed to the event.¿ in this event, due to the limited information provided on the ¿significant injury,¿ a critical/serious injury cannot be excluded at this time.Additionally due to the customer statement of, ¿possibly a patient weight was not taken prior to arming the bed exit,¿ use error cannot be ruled out.If any new relevant information is received the complaint will be addressed accordingly.Based on this information, no further action is required.

Event Description

The customer reported that a patient fall occurred resulting in ¿significant injury.¿ the customer did not provide details of the injury; however, the patient was described as a ¿bigger man, had been in the icu previously for (she believed) a stroke, and had also fallen earlier that day.¿ it could not be confirmed that the bed was a hillrom device, and no serial/model number was provided.The bed was located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: VERSACARE 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: 16141446
• MDR Text Key: 307126020
• Report Number: 1824206-2023-00023
• 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: 01/11/2023

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: P3200K000500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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