PORTEX
Received Jan 27, 2021 · Event occurred Nov 10, 2020
Report 3012307300-2021-00678 · MDR key 11237216
Device
Generic name
Cuff Inflator Pressure Gauge
Catalog number
100/568/000
Lot number
3982241
Product problems
- Inaccurate Information
- Inaccurate Information
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
OTHER TEXT: RETURNED DEVICE WAS RECEIVED FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE THE CUSTOMER REPORTED CONDITION WAS CONFIRMED. PROBLEM SOURCE IS UNKNOWN. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.
Description of Event or Problem
INFORMATION WAS RECEIVED THAT DEVICE IS NOT WORKING. WHEN PRESSED, IT DOES NOT MOVE AND DOES NOT MOVE FROM 120. UPON INFLATING, INSTEAD OF GOING FROM 0 TO 120 IT GOES FROM 120 TO 0. THE EVENT OCCURRED DURING THE USE. THE PRODUCT WAS IMMEDIATLY REPLACED TO SUPPORT THE PATIENT.