MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION COMPELLA SURACE; BARIATRIC BED

Model Number	P642AREN0100000
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report from a baxter technician to report the compella air mattress, na, r power cord sparked and smoked due to short.The bed was located at the account.This occurred during patient use.The reporter did not know if there was any patient injury or medical intervention associated with this event.It was unknown if any second device was also involved.The customer did not know if this event was already communicated to another baxter department or authority.
Additional Manufacturer Narrative
The baxter technician found the power cord needed to be replaced.Per the bater 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 baxter maintenance records did not show baxter performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the power cord to resolve the reported event.Based on this information, no further action is required.

• Brand Name: COMPELLA SURACE
• Common Device Name: BARIATRIC BED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM MEXICO; ave.del telefono; no. 200 col. huinala; apodaca 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20821279
• Report Number: 3006697241-2024-00163
• Device Sequence Number: 15416568
• Product Code: OSI
• UDI-Device Identifier: 00887761996717
• UDI-Public: (01)00887761996717(11)170201
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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: P642AREN0100000
• Device Catalogue Number: P642AREN0100000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown