MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SYNERGY AIR ELITE BLOWER; BED, FLOTATION THERAPY, POWERED

Model Number	P6881
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the power cord needed to be replaced.Per the hillrom service manual, inspect the power cord for damage, twisting, and replace if 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 swapped the blower to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
On 23-sep-2024, a customer contacted technical service to report that blower assembly, sae (product code p6881, serial number (b)(6)), had an issue, cord sliced in half.This occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.The customer already communicated this event to another baxter department or authority: through jde.The device was requested for service/inspection by baxter.

• Brand Name: SYNERGY AIR ELITE BLOWER
• Common Device Name: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20481893
• Report Number: 1824206-2024-01476
• Device Sequence Number: 8275852
• Product Code: IOQ
• UDI-Device Identifier: 00887761016552
• UDI-Public: (01)00887761016552
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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: P6881
• Device Catalogue Number: P6881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 10/18/2024
• 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