SPIROPERFECT
Received Aug 11, 2023
Report MW5123318 · MDR key 17516369
Device
Generic name
Spirometer, Diagnostic
Manufacturer
Medikro OyProduct problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
510(K):K971336, WELCH ALLYN BECAME AWARE THROUGH A DISTRIBUTOR IN THE NETHERLANDS THAT THEIR CUSTOMER EXPERIENCED A PROBLEM WITH THE FLOW TRANSDUCERS. TWICE WHEN SHE WANTED A PATIENT TO INHALE TO START THE SPIROMETER MEASUREMENTS A SMALL PIECE OF PLASTIC CAME OFF THE TUBE. THERE WAS NO REPORT OF THE OBJECT GOING INTO THE PATIENT'S WINDPIPE/TRACHEA. WELCH ALLYN CONTACTED THE COMPLAINANT AND REQUESTED THE DEVICES TO BE RETURNED FOR FURTHER EVALUATION. TO DATE, WELCH ALLYN HAS NOT RECEIVED THE DEVICES FROM THE USER. IF WE RECEIVE THE DEVICES, WE WILL FORWARD THEM TO THE MANUFACTURER MEDIKROOY FOR EVALUATION. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).