MAUDE Adverse Event Report: HILL-ROM BATESVILLE COMPELLA RENT US SCALE PD PPM; BED, FLOTATION THERAPY, POWERED

Model Number P7800ARENT01

Device Problem Mechanical Jam (2983)

Patient Problem Scar Tissue (2060)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

The hillrom technician found the side rails were not expanded causing the turn to not work, expanded the sides and the foot section and reset the blower the issue was resolved.No malfunction with the bed.Per the hillrom service manual the compella bed requires an effective maintenance program.We recommend that you perform annual preventative maintenance.Pay particular attention to safety features, which include but are not limited to: controls return to off or the neutral position when released.Make sure that the controls are in good condition and that the membranes are not worn or torn.Do the function checks.Make sure that the bed does not fail any of the function checks.Replace or repair parts as necessary.During a follow-up call with the customer september 8, 2021, the customer stated it is likely the feature was not being used properly and it is unclear how long the feature was not in use.The compella bariatric bed system is for bariatric patients of all age groups with varying medical and physical conditions.The compella 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 continuous lateral rotation therapy (clrt).The intended users of the compella bed are healthcare employees who have the physical strength and cognitive skills to operate and control the bed.Follow facility safety protocols if an intended user does not have the physical strength or cognitive skills to operate and control the bed.The bed's turn feature assists the caregiver to turn (position) the patient to the left or right for a 30-minute increment.Inspection of the bed by a hillrom technician found the bed to be functioning as designed, the bed's side rails were not expanded preventing the turn assist feature from operating as a safety precaution.The ifu notes during clrt and turn assist, risk of a patient fall is present if the side rails are retracted.The technician expanded the sides and the foot section, the issue was resolved.Based on the report that the bed's turn assist feature was not being used properly, it is likely that the patient's injury can be contributed to misuse of the device, (not extending the side rails).Additionally, the patient's deep tissue injury required surgical intervention and therefore meets the definition of a reportable serious injury.Thus this event is reportable.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in april 2021.It is unknown if the facility performed any other preventative maintenance on this bed.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the bed the turn feature of the compella bed was not working and the patient developed a sacral deep tissue injury.The bed was located at the account.There was patient injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: COMPELLA RENT US SCALE PD PPM
• Type of Device: BED, FLOTATION THERAPY, POWERED
• 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: 12470717
• MDR Text Key: 271368485
• Report Number: 1824206-2021-00466
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/14/2021

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 Operator: No Information
• Device Model Number: P7800ARENT01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• 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