FDA Adverse Event Malfunction Summary report: N

PROGRESSA BED SYSTEM

MDR report key: 22559457 · Received July 21, 2025

Report

Report Number
1824206-2025-01304
Event Type
Malfunction
Date Received
July 21, 2025
Date of Event
May 9, 2025
Report Date
July 21, 2025
Manufacturer
BAXTER HEALTHCARE CORPORATION
Product Code
FNL
UDI-DI
00887761000100
PMA / PMN Number
NA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
WV, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 0

THE BAXTER TECHNICIAN FOUND THE POWER CORD NEEDED TO BE REPLACED. IT IS NECESSARY FOR THE PROGRESSA BED TO HAVE AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU DO ANNUAL PREVENTIVE MAINTENANCE. EXAMINE THE PLUG FOR DAMAGE. MAKE SURE THE PLUG IS A ONE-PIECE MOLDED PLUG ASSEMBLY. IF IT IS NOT, REPLACE THE PLUG CORD ASSEMBLY. REPLACE ANY PLUG CORD ASSEMBLY THAT SHOWS: DISCOLORATION OF THE PLUG MOLDING, ANY SIGNS OF CRACKING, OR LOOSE FIT OF THE PLUG BLADE. REPLACE THE POWER CORD, IF DAMAGED. 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.

Description of Event or Problem · 0

BAXTER RECEIVED MEDWATCH 5171713 REPORTING A PROGRESSA FRAME HAD A POWER CORD THAT SPARKED AND SMOKED. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED. THERE WERE NO OTHER DEVICES REPORTED TO BE INVOLVED. THE CUSTOMER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2731171 PROGRESSA BED SYSTEM BED, AC-POWERED ADJUSTABLE HOSPITAL FNL BAXTER HEALTHCARE CORPORATION P7500A NI 00887761000100

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown