FDA Adverse Event Malfunction Summary report: N

NOVAPLUS LIGHTWEIGHT SINGLE HEAD STETHOSCOPE

MDR report key: 21000083 · Received December 23, 2024

Report

Report Number
21000083
Event Type
Malfunction
Date Received
December 23, 2024
Date of Event
December 3, 2024
Report Date
December 18, 2024
Manufacturer
KERMA MEDICAL PRODUCTS, INC
Product Code
LDE
Product Problem
Yes
Report Source
User Facility report
Reporter Location
PA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

THE BEDSIDE NURSING STAFF, AND OUR PHYSICIAN COLLEAGUES, CONSISTENTLY STRUGGLE WITH THE YELLOW DISPOSABLE STETHOSCOPES (ITEM #372385). THE PRIMARY ISSUE BEING THAT THEY CANNOT BE RELIED UPON TO ADEQUATELY HEAR AND ASSESS LUNG, HEART, AND BOWEL SOUNDS. NOVAPLUS LIGHTWEIGHT SINGLE HEAD STETHOSCOPE IN YELLOW. CATALOG NUMBER: V4630A. LOT NUMBER 2403HS06A. FROM PROVIDER: "I CAN CHIME IN THE USE OF THESE STETHOSCOPES. WHILE I'M SURE THE GOAL FOR USING THESE STETHOSCOPES IS TO LIMIT USE TO ONLY PATIENTS ON ISOLATION PRECAUTIONS, MY EXPERIENCE IS THAT THEY ARE BEING UTILIZED MORE FREQUENTLY IN NON-INFECTIOUS ROOMS AS PROVIDERS HAVE BECOME MORE AWARE OF THE INFECTIOUS RISKS OF SHARING EQUIPMENT, INCLUDING THEIR OWN PRIVATELY PURCHASED STETHOSCOPES, BETWEEN PATIENTS. THERE HAVE BEEN ENOUGH OCCASIONS WHERE A PATIENT IS INITIALLY BELIEVED TO BE NONINFECTIOUS, ONLY TO TEST POSITIVE FOR INFECTIOUS PATHOGENS THAT REQUIRE ISOLATION LATER THAT DAY THAT PROVIDERS HAVE USED ISOLATION STETHOSCOPES MORE FREQUENTLY. ADDITIONALLY, AS WE ENTER RESPIRATORY SEASON, A GREATER NUMBER OF PATIENTS ARE ON ISOLATION AND THE IMPORTANCE OF AN ACCURATE RESPIRATORY ASSESSMENT BECOMES CRUCIAL. HENCE THE GROWING EFFORT FOR AN IMPROVED PRODUCT."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2628436 NOVAPLUS LIGHTWEIGHT SINGLE HEAD STETHOSCOPE STETHOSCOPE, MANUAL LDE KERMA MEDICAL PRODUCTS, INC V4630A 2403HS06A

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown