Description of Event or Problem · 1
MEDICAL RESEARCH LABORATORIES - MRL - MANUFACTURES AND DISTRIBUTES PORTABLE BATTERY-OPERATED CARDIAC MONITORS/DEFIBRILLATORS FOR AMBULANCE USE. THE DEVICES ARE SUPPLIED WITH PROPRIETARY RECHARGEABLE BATTERIES HAVING A USEFUL LIFE OF TWO YEARS, AND ARE LABELED WITH A DATE CODE REFLECTING THE EXPIRATION DATE. CURRENTLY, MRL IS UNABLE TO SUPPLY REPLACEMENT BATTERIES, CLAIMING IT HAS ENCOUNTERED A "SUPPLIER PROBLEM". REPORTING CO ORDERED BATTERIES OVER TWO MONTHS AGO, AND TO DATE HAS NOT RECEIVED A SHIPMENT. RPTR BELIEVES THIS ISSUE POSES A SERIOUS RISK OF INJURY OR DEATH, WHEREAS MRL HAS HUNDREDS OF THESE DEVICES IN USE THROUGHOUT THE COUNTRY. THE OPERATING TIME OF THE DEVICE IS SIGNIFICANTLY SHORTENED WHEN THE BATTERY APPROACHES THE END OF ITS USEFUL LIFE. IT IS HIGHLY PROBABLE THAT SOME USERS WOULD EXPERIENCE BATTERY DEPLETION WHILE MONITORING AND/OR DEFIBRILLATING A PT. ALTHOUGH VEHICLE-POWERED BATTERY ELIMINATORS ARE AVAILABLE, NOT ALL PROVIDERS HAVE THEM. RPTR'S FIRM HAS BATTERY ELIMINATORS AS A BACKUP SYSTEM. RECHARGING THE BATTERIES IN THE VEHICLE IS NOT PRACTICAL, DUE TO THE TIME CYCLE REQUIRED. PLEASE NOTE THAT RPTR SPOKE WITH MRL. ALTHOUGH RPTR ORDERED 8 BATTERIES, THEY INDICATED THEY WOULD "TRY TO SEND ME 3" AND THAT THE CO WAS "RATIONING ORDERS". RPTR HAS NOT YET RECEIVED EVEN 3 BATTERIES. IN RPTR'S OPINION, MRL SHOULD BE MANDATED TO SUPPORT THE EQUIPMENT OR REPLACE IT WITH DEVICES FOR WHICH BATTERIES ARE IMMEDIATELY AVAILABLE.