MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION COMPELLA SURFACE; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	P642AREN0100000
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient sustained an unstageable pressure ulcer in conjunction with a compella mattress.The patient stated when they ¿raised their head and knees they could feel the metal part of the bed.¿ the patient was found to have a new open area on the patient¿s buttocks.The nurse was unable to stage the wound due to ¿minimal slough noted.¿ additionally, the wound was measured at 2.2 cm x 1.5 cm x 0.1 cm (estimated).The patient was treated with medihoney and collagen application to the wound and covered with a dry protective dressing.The baxter service technician inspected the bed.The technician noted the bed¿s cpr valve was open, putting the bed into cpr mode and causing the mattress to deflate.The technician closed the cpr valve to resolve the issue, and the bed is functioning as designed.The cause of the event is likely due to the bed¿s cpr mode being engaged which did not allow the bed¿s mattress to reinflate (user error).When the cpr function is engaged/activated air is released from the bed¿s surface until the surface is completely deflated.The device instructions for use state the following when using the bed¿s cpr controls.¿to inflate the air surface after cpr 1.Turn the air surface cpr mechanism counterclockwise until it locks into position.2.On the air supply unit, press max inflate to quickly inflate the surface.3.After the surface is fully inflated, press max inflate again to toggle it off.¿ there was no malfunction of the bed, as the inspection found the bed to be functioning as designed upon disengaging the cpr mode to reinflate the surface.Prevention of this type of event is outlined in the device instructions for use.No further information was available at the time of this report.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, h6 and h11.H11: the device was evaluated on-site by a baxter technician.The device underwent functional testing and the cpr valve was found open.To fix this issue the cpr valve was closed.Additionally, according to the design of this device the expected life for the mattress is 5 years.The mattress associated with this complaint was more than 5 years old; therefore, the alleged deficiency is considered normal wear.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: COMPELLA SURFACE
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM MEXICO; ave.del telefono; no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22954436
• Report Number: 3006697241-2025-00237
• Device Sequence Number: 18256044
• Product Code: FNL
• UDI-Device Identifier: 00887761996717
• UDI-Public: (01)00887761996717
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: P642AREN0100000
• Device Catalogue Number: P642AREN0100000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown