MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TOTALCARE BED; BARIATRIC BED

Model Number	PR1900DL000008
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A other health care professional contacted technical service to report that the totalcare bed is not working while plugged into the wall.The customer stated that they unplugged the power cord from the wall and when they reached down to unplug the power cable from the pcm board it sparked and burnt the board upon removal.The process step during which this occurred was unknown.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The device was not requested for service since troubleshooting and solution was provided via phone where it was determined that the pcm board would need to be replaced to resolve the issue.The totalcare bariatric bed or totalcare bariatric plus therapy system is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The totalcare bariatric bed or totalcare bariatric plus therapy system is intended to provide a patient support to be used in health care environments.The totalcare bariatric bed or totalcare bariatric plus therapy system may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acute sub-acute care, post anesthesia care unit and sections of the emergency department.The part # for a replacement pcm board was provided to the customer to resolve the reported event.Based on this information, no further actions are required.Although there was no reported injury associated with this event if the power cord were to spark during use it could lead to serious injury or death.

• Brand Name: TOTALCARE BED
• Common Device Name: BARIATRIC BED
• 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: 20570203
• Report Number: 1824206-2024-01521
• Device Sequence Number: 12719677
• Product Code: OSI
• UDI-Device Identifier: 00887761999596
• UDI-Public: (01)00887761999596
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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
• Operator of Device: Other
• Device Model Number: PR1900DL000008
• Device Catalogue Number: PR1900DL000008
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/30/2024
• 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
• Patient Sex: Unknown