Description of Event or Problem · 1
IN 9/92, THESE BEDS REPLACED ALL BEDS THROUGHOUT THE HOSP EXCEPT THE CRITICAL CARE AND THE MENTAL HEALTH UNITS. IN THE MONTHS FOLLOWING, THE HOSP BECAME AWARE OF AN INCREASE IN THE NUMBER OF PTS WITH VARYING DEGREES OF SKIN BREAKDOWN ON THE HEELS, PARTICULARLY ON THE ORTHO/NEURO UNITS. THE CO REP WAS CONTACTED. HE STATED THAT HE WAS UNAWARE OF ANY SIMILAR COMPLAINTS, BUT SUGGESTED THAT BEDS BE PLACED IN THE "PREVENTION MODE." DIALOGUE CONTINUED WITH CO WITH A MEETING ON 1/13/92 BETWEEN HOSP REPS AND CO SALES REPS. AT THE MEETING, CO REPS AGREED TO REPLACE THE TOP LAYER OF THE MATTRESS WITH A LESS DENSE FOAM. THEY STATED THAT THIS HAD RESOLVED THE PROBLEM IN ANOTHER HOSP. IN MID-MAY, THE HOSP CONTACTED OTHER FACILITIES USING THESE BEDS AND WAS TOLD OF SIMILAR EXPERIENCES WITH INCREASED HEEL BREAKDOWN. CO COMMISSIONED THEIR PRODUCT ENGINEERS TO TEST THE "PRESSURE POINTS" ON THE MATTRESS. CO IDENTIFIED THAT THE PRESSURE ON THE HEEL AREA WAS HIGHER THAN THAT OF AN INNER SPRING MATTRESS AND WITH AN EGGSHELL OVERLAY. IN ALL OTHER AREAS OF THE MATTRESSES, THE PRESSURE WAS SIGNIFICANTLY LESS THAN THE MATTRESS/EGGSHELL COMBINATION. CO AGREED TO REPLACE THE TOP COVER OF THE MATTRESS. THE NEW COVER WAS MADE TO ALLOW MORE GIVE IN THE DISTAL PORTION OF THE BED. CO COMPLETED THE REPLACEMENTS BY 7/93. HEEL BREAKDOWNS HAVE BEEN MONITORED CONTINUOUSLY THROUGHOUT THIS PERIOD AND HAVE SUBSTANTIALLY DECREASED SINCE JULY. DURING THE TIME FRAME BETWEEN PURCHASE OF BEDS AND 7/93, (WHEN REPLACEMENT OF THE TOP COVERS WAS COMPLETE) THERE WERE 39 PTS IDENTIFIED WITH HEEL BREAKDOWN. ONLY ONE PT SUSTAINED INJURY SUCH THAT MEDICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT. THIS PT WAS ADMITTED 11/23/92 WITH A LEFT HIP FRACTURE. SURGERY WAS PERFORMED ON 11/24/92. TWO DAYS POST-OP, SHE DEVELOPED HEEL REDNESS; HEEL PROTECTORS WERE APPLIED. ON 12/6/93, THE HEEL ULCER WAS DRAINING. THE HEEL WAS ELEVATED WITH HEEL PROTECTOR IN PLACE. SHE WAS TRNASFERRED TO A REHAB CTR ON 12/8/92. ON 2/8/93, PT WAS RE-ADMITTED WITH A NON-HEALING ULCER ON THE LEFT HEEL. ADMISSION NOTE STATED, "DEVELOPED DURING HOSPITALIZATION, FAILED TO HEAL WITH CONSERVATIVE TREATMENT." DEBRIDEMENT AND SPLIT THICKNESS SKIN GRAFT WAS PERFORMED ON 2/9/93. PT WAS DISCHARGED ON 2/16/93. BASED ON THE TRENDING DATA, THE HOSP FEELS THAT THERE WAS A CORRELATION BETWEEN THE BEDS, AS ORIGINALLY MFG, AND THE HEEL BREAKDOWN PROBLEM.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JUL-92. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: OTHER. CONCLUSION: OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.