MAUDE Adverse Event Report: HILL-ROM MEXICO COMPELLA CONTROLLER; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number P7810ACT3A0ENG1

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2023

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the power cord needed to be replaced.Per the hillrom service manual it is necessary for the compella® bariatric bed to have an effective maintenance program.We recommend that you do annual preventive maintenance.Pay particular attention to safety features, which include but are not limited to: the power cords for the bed and asu are with the unit, and they are in good condition: the plug is a one-piece molded plug assembly, the assembly shows no signs of cracking, the plug molding around the blade is not discolored, and the blade is tight in the molding.The power cord hooks shows no sign of cracking and are intact with no damage.Replace or repair parts as necessary.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed on january 2023.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the power cord to resolve the reported event.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the the blower's power cord was cut, copper wires were showing.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: COMPELLA CONTROLLER
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 16573906
• MDR Text Key: 311707939
• Report Number: 3006697241-2023-00020
• Device Sequence Number: 1
• Product Code: IKY
• 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: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P7810ACT3A0ENG1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 03/20/2023
• 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