RAYE'S, INC DBA SIZEWISE MANUFACTURING

Description of Event or Problem

ON 5/13/2025 AGILITI RECEIVED A CALL FROM THE FACILITY STATING THAT THE BED WAS DROPPING DOWN TO LOW POSITION BY ITSELF. ON 6/20/2025 AGILITI RECEIVED FDA LETTER AND MEDSUN FORM 3500A (B)(4) THAT WAS SUBMITTED BY (B)(6) HOSPITAL STATING PATIENT INVOLVEMENT AND THE FOLLOWING. "THE PATIENT WAS UTILIZING A "LOANER" BED WITH AIR MATTRESS CAPABILITIES. THIS REPORTER LOWERED THE BED AFTER PERFORMING PATIENT CARE AND APPROXIMATELY 30 SECONDS AFTER PLACING THE BED IN THE LOWEST POSITION AVAILABLE FOR SAFETY, THE BED DROPPED MAKING A "BOOM" SOUND. THE BED HAD DROPPED TO THE FLOOR."

Additional Manufacturer Narrative

UPON INITIAL REVIEW OF THIS REPORT AGILITI DID NOT FEEL THAT AN MDR WAS NECESSARY. EVALUATION WAS COMPLETED AND THE PROBLEM WAS UNABLE TO BE CONFIRMED AS REPORTED. AFTER RECEIVING UPDATED INFORMATION ON 6/20/2025 THE DECISION WAS MADE TO SUBMIT AN MDR OUT OF ABUNDANCE OF CAUTION DUE TO AN EDGE CASE WHERE A PATIENT COULD BE SITTING ON THE EDGE OF THE BED, IF THE BED SUDDENLY DROPPED, THE PATIENT COULD FALL FROM THE BED WHICH COULD CAUSE FRACTURES THAT WOULD REQUIRE SURGICAL INTERVENTION. NOTE: (B)(6) HOSPITAL REPORTED AN IMMERSE BLOWER WCF1629 WITH SERIAL NUMBERS (B)(6) (B)(6) IN THEIR REPORT, RATHER THAN THE APPLICABLE EVOLUTION BEDFRAME NOTED IN THIS REPORT.