PORTEX CUFF INFLATOR PRESSURE GAUGE W CONNECTING T
Received Sep 20, 2022
Report 3012307300-2022-19816 · MDR key 15456867
Device
Generic name
Monitor, Airway Pressure (includes Gauge And/or Al
Catalog number
100/568/000
Lot number
3874264
Product problems
- Defective Device
- Defective Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE PRESENTED DEFECTIVE. NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
MANUFACTURING SITE ADDRESS IS UNKNOWN. PREMARKET (510K) NUMBER IS UNKNOWN. UDI INFORMATION IS UNKNOWN. ONE USED DECONTAMINATED SAMPLE WAS RECEIVED FOR INVESTIGATION. UNDER VISUAL INSPECTION THE SAMPLE APPEARED TO BE IN GOOD CONDITION, AND NO PHYSICAL DAMAGE WAS OBSERVED. THE POINTER WAS STACKED AND WAS NOT RETURNING TO ZERO POSITION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCT. PER THE SUPPLIER, THIS ISSUE CAN OCCUR IF THE DEVICE IS DROPPED OR DAMAGED. THE ROOT CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).