VERSACARE P500
Received Nov 21, 2024 · Event occurred Apr 18, 2024
Report MW5162879 · MDR key 20760912
Device
Generic name
Bed, Flotation Therapy, Powered
Manufacturer
Hill-rom, Inc.Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
NATIONWIDE PATIENT ALERT, AL24-01 ISSUED ON APRIL 18, 2024, REGARDING "UNDETECTED FLUID INGRESS AND EGRESS FROM INPATIENT AND OUTPATIENT MATTRESSES CAN LEAD TO HOSPITAL-ASSOCIATED INFECTIONS, PATIENT TISSUE DEGRADATION, AND/OR PATIENT DEATH." A FACILITY-WIDE AUDIT AT THE (B)(6) WAS CONDUCTED ON ALL MATTRESSES AND STRETCHERS IN QUESTION AND A TOTAL OF 66 MATTRESSES WERE IDENTIFIED AS MEETING THE CRITERIA RELATED TO THE ALERT AND HAVING PINHOLES, TEARS, CUTS, CRACKS, TEARS, STAINS, INTRUSION OR COMPROMISED FIRE BARRIERS. THESE PRODUCTS ARE IN THE PROCESS OF BEING PROCURED AND REPLACED AT THE AFFECTED AREAS LISTED BELOW. COUNT BY FACILITY LOCATION AND MATTRESS TYPE AFFECTED: COMMUNITY LIVING CENTER 1 - CARE ASSIST (27) CENTRELLA (9), VERSACARE (0). COMMUNITY LIVING CENTER 2 - CARE ASSIST (8), CENTRELLA (13), VERSACARE (2), ULTRACARE (1), COMFORT GEL (1). COMMUNITY LIVING CENTER 3 - CARE ASSIST (1), CENTRELLA (3), VERSACARE (1). REFERENCE REPORTS MW5162818, MW5162819, MW5162820, MW5162821, MW5162822, MW5162823, MW5162824, MW5162825, MW5162826, MW5162827, MW5162828, MW5162829, MW5162830, MW5162831, MW5162832, MW5162833, MW5162834, MW5162835, MW5162836, MW5162837, MW5162838, MW5162839, MW5162840, MW5162841, MW5162842, MW5162843, MW5162844, MW5162845, MW5162846, MW5162847, MW5162848, MW5162849, MW5162850, MW5162851, MW5162852, MW5162853, MW5162854, MW5162855, MW5162856, MW5162857, MW5162858, MW5162859, MW5162860, MW5162861, MW5162862, MW5162863, MW5162864, MW5162865, MW5162866, MW5162867, MW5162868, MW5162869, MW5162870, MW5162871, MW5162872, MW5162873, MW5162874, MW5162875, MW5162876, MW5162877, MW5162878, MW5162880, MW5162881, MW5162882, MW5162883.