FDA Targets BEKA Hospitec for MDR, Complaint Issues

The FDA cited a German medical device manufacturer for noncompliance issues related to MDR reports, complaint handling, as well as device master records and history records.

The agency’s Form 483 report issued after inspecting the facility from Jan. 30 to Feb. 2 observed that MDR and complaint reports were not completed after several events that called for them, including the firm’s Carlo lift lowering onto a patient’s face leaving a bruise, a lift bar “breaking at the swivel connection point just after the patient was transferred to a bed,” and a lift shaft bolt “shearing while a patient was in the lift, causing the patient to fall and the carry bar to fall on the patient’s chest.”

The investigator also observed that BEKA Hospitec had not established design validation protocols and acceptance criteria before performing validation activities on its Sina Comfort Shower Trolley.