inforMED
InjuryFMW

SOTERIA BED BARRIER (MATRESS COVER)

Received Jun 28, 2019 · Event occurred May 24, 2019

Report MW5087710 · MDR key 8749226

Device

Generic name

Cover Matress

Manufacturer

Trinity Guardion

Model number

ISOLIBRIUM COVER

Product problems

  • Device-Device Incompatibility

Patient

33 YR

  • Fall
  • Fall

Narrative

Description of Event or Problem

ICU PATIENT'S BED SCREEN NOT WORKING AND BED DID NOT ALARM WHEN PATIENT WAS FOUND ON FLOOR NEXT TO BED. DETERMINED THAT THE BED ALARM DID NOT FUNCTION PROPERLY DUE TO MATTRESS COVER. THE HEADBOARD WAS NOT ABLE TO SIT PROPERLY AND PREVENTED THE BED ALARM FROM FUNCTION/ALARMING DESPITE BEING TURNED ON. SCENARIO WAS REPLICATED WITH REPRESENTATIVES FROM STRYKER AND TRINITY GUARDIAN (COVER MANUFACTURER) PRESENT; NON-FUNCTIONING OF THE BED/CPR STRAP NOTED WITH THE MATTRESS COVER IN PLACE ON ISOLIBRIUM BED. A CUSTOM BED BARRIER (MATTRESS COVER)- ALSO KNOWN AS ISOLIBRIUM MATTRESS COVERS-MANUFACTURED BY TRINITY GUARDIAN WAS IN USE ON AN ICU BED AT (B)(6) HOSPITAL WHEN IT WAS DETERMINED THAT THE BED ALARM DID NOT PROPERLY FUNCTION DUE TO THE MATTRESS COVER. THE PATIENT WAS FOUND ON THE FLOOR BY STAFF DESPITE THE BED SCREEN (ALARM) BEING ON. THE BED WAS A STRYKER IN-TOUCH BED WITH AN ISOLIBRIUM MATTRESS. BED MODEL REF# FA64228. BED INFORMATION: U55471. POST-INCIDENT INSPECTION CONDUCTED BY STRYKER AND HOSPITAL QUALITY SPECIALISTS WHO NOTED THAT THE ALARM WAS ON BUT DUE TO THE MATTRESS COVER THE FOOTBOARD WAS NOT ABLE TO SIT PROPERLY THEREBY PREVENTING THE SCREEN FROM LIGHTING UP. IT WAS SEPARATELY NOTED THAT THE CPR STRAPS WERE UNABLE TO ACTIVATE DUE TO THE SIZE OF THE OUTLET FOR THE STRAP IN THE MATTRESS COVER. FOLLOWING THIS DETERMINATIONS, ALL MATTRESS COVERS WERE REMOVED FROM ISOLIBRIUM BEDS UNTIL THE MATTRESS COVER CAN BE REDESIGNED AND TESTED SO THAT IT DOES NOT INTERFERE WITH ALARMS. IT SHOULD FURTHER BE NOTED THAT THE MATTRESS COVERS WERE SPECIFICALLY MANUFACTURED FOR THE BED/MATTRESS WITH THE BED ALARM AND CPR STRAPS FULLY FUNCTIONAL. DURING THE INVESTIGATION AND REPLICATION OF THE EVENT ON THE SAME BED/MATTRESS MODEL UTILIZING THE SAME BED BARRIER PRODUCT, IT WAS NOTED THAT THE BED ALARM WAS UNABLE TO ACTIVATE AND THE COVER WAS RIPPING IN THE AREA OF THE CPR STRAPS. IT SHOULD ALSO BE NOTED THAT THE ORIGINAL BED/MATTRESS WERE EVALUATED, THE MATTRESS COVER WAS REMOVED, THE MATTRESS COULD BE RESET BY PULLING ON THE CPR STRAPS, THE MATTRESS WAS THEN FUNCTIONAL AND THE ERROR WAS RESOLVED.