FDA Adverse Event
Malfunction
Summary report: N
SPIROPERFECT
MDR report key: 17516369
·
Received August 11, 2023
Report
- Report Number
- MW5123318
- Event Type
- Malfunction
- Date Received
- August 11, 2023
- Report Date
- March 10, 2011
- Manufacturer
- MEDIKRO OY
- Product Code
- BZG
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
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).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2192595 | SPIROPERFECT | SPIROMETER, DIAGNOSTIC | BZG | MEDIKRO OY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |