Description of Event or Problem · 1
THIS IS A PRODUCT QUALITY COMPLAINT CONCERNING THE SCOTTCARE CORP., TELEREHAB CARDIAC TELEMETRY TRANSMITTER MODEL: DS2 608-614MHZ. THESE TRANSMITTERS ARE COMMONLY USED TO MONITOR THE HEART RHYTHMS OF CARDIAC REHAB PTS DURING REHABILITATION VISITS. THE PROBLEM WITH THE TRANSMITTERS ARE WITH THE TRANSMITTER ENDCAP ASSEMBLY WHICH SERVES TO HOLD THE BATTERY INSIDE THE UNIT. WITHOUT THE END CAP IN PLACE, THE TRANSMITTER DOES NOT FUNCTION. THE DEFECT IS THE SINGLE SCREW THAT HOLDS THE ENDCAP AND BATTERIES INSIDE THE TRANSMITTER. IN ORDER TO TURN THE TRANSMITTER ON OR OFF OR TO REPLACE THE BATTERIES, ONE MUST SCREW THIS SCREW IN AND OUT WITH THE ATTACHED KNOB. THE THREADS OF THIS SCREW COMPLETELY FALL OFF OF THE SCREW, AND THE ENDCAP FALLS OFF DURING PT USE WHILE THEY ARE POSSIBLY ON A TREADMILL OR BICYCLE ENDANGERING THE PT AND LOSING THE NEEDED CARDIAC RHYTHM DATA. THIS WOULD MAKE IT IMPOSSIBLE TO RECORD AN ADVERSE PT EVENT AND EVEN POSSIBLY CAUSE ONE. I HAVE WORKED AT SEVERAL DIFFERENT HOSPITALS THAT USE THIS DEVICE AND THIS HAS BEEN AN ONGOING AND RECURRING PROBLEM WITH THIS TRANSMITTER. THE MFR HAS BEEN NOTIFIED AND THE ONLY SOLUTION THEY OFFER IS TO PURCHASE ANOTHER ENDCAP. THIS IS NOT SATISFACTORY FOR A PRODUCT TO HAVE SUCH A MAJOR DEFICIENCY, ONE THAT COULD POSSIBLY TRIGGER AN ADVERSE EVENT AND ONE THAT MAKES THE PROPER AND SAFE TREATMENT UNAVAILABLE TO OUR PTS DURING THEIR REHABILITATION WHEN THEY NEED IT MOST. IN MY OPINION, THIS PROBLEM COULD BE FIXED EASILY THROUGH THE USE OF THE PROPER GRADE OF METAL USED TO MFR THE SCREW. DATES OF USE: 2006 - 2008. DIAGNOSIS OR REASON FOR USE: CARDIAC MONITORING USING TELEMETRY TRANSMITTER.