MAUDE Adverse Event Report: HILL LABORATORIES CO HILL LABORATORIES CO; HA90V

Model Number	HA90V
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Device Emits Odor (1425); Device Remains Activated (1525); Unintended Movement (3026)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No complaint was received by hill laboratories directly from the facility, however a parts order for a replacement board, and tilt actuator was received for the device (serial number: (b)(6) on 6/19/2025 and shipped on 6/24/2025.Hill laboratories requested a contact name and phone number from the initial reported in the mdr and made multiple attempts to contact the individual to complete the investigation but received no response.The event description in mdr report#: mw5171894 likely points to a latched relay in the device's circuit board that impacted communication between the foot pedal and the liftback / tilt actuator.With the relay likely latched, the tilt actuator likely kept running - causing the table to tilt patient into reverse trendelenberg position, the smell of burning electric parts and subsequent tissue injury by the staff when attempting to secure the patient.Although component malfunctions can occur, this type of malfunction is rare.Usually, the tilt motor does not move once a relay is latched.Data analysis noted an increase in relay issues starting in 2023.A new board version was initiated in 2024 and then approved by the engineering team in 2025 which addresses the latched relay.The customer received the latest version board.A seatbelt option exists for this device but was not purchased by the customer in 2017.Hill laboratories is initiating a review of this option with the intent of making the seatbelt a standard feature along with revised instructions in the user manual.
Event or Problem Description
Following patient treatment, staff attempted to reposition the bed to bring into standard prone position.The bed had no electric response to foot controls but continued to tilt patient into reverse trendelenburg position.Staff was able to secure patient and assist to standing position without patient injury however the physician was injured while protecting the patient from a fall.The motor was noted to continue to run and smelled of burning electric parts.

• Brand Name: HILL LABORATORIES CO
• Common Device Name: HA90V
• Manufacturer (Section D): HILL LABORATORIES CO; 3 n bacton hill rd; frazer PA 19355
• Manufacturer (Section G): HILL LABORATORIES CO; 3 n bacton hill rd; frazer PA 19355
• Manufacturer Contact: ben aller ; 3 n bacton hill rd; frazer, PA 19355 ; 6106442867
• MDR Report Key: 22556503
• Report Number: 2510425-2025-00001
• Device Sequence Number: 9529090
• Product Code: INQ
• UDI-Device Identifier: 00850058158082
• UDI-Public: 850058158082
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K931832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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: HA90V
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2017
• 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: Other
• Patient Sex: Unknown