UNKNOWN
Report
- Report Number
- 2411797-2026-00001
- Event Type
- Malfunction
- Date Received
- March 23, 2026
- Date of Event
- January 26, 2026
- Report Date
- March 20, 2026
- Manufacturer
- UNKNOWN
- Product Code
- ELC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
PARKELL WAS INFORMED THAT MEDSUN FILING (B)(4), (B)(6) HOSPITAL WAS IN ERROR. THE DEVICE INVOLVED WAS NOT A PARKELL DEVICE.
PARKELL, INC. IS FILING A CAUTIONARY REPORT IN RESPONSE TO A DISCREPANCY DISCOVERED IN THE MAUDE DATABASE (REPORT (B)(4)). THE COMPANY IDENTIFIED SEVERAL INCONSISTENCIES THAT SUGGEST THE REPORT MAY BE INACCURATE OR MISATTRIBUTED: SUMMARY OF KEY ISSUES: IDENTIFICATION DISCREPANCY: THE REPORT LISTS MODEL D410 AND CATALOG D419, NEITHER OF WHICH ARE VALID PARKELL DEVICE NUMBERS. CLINICAL INCONSISTENCY: THE EVENT DESCRIPTION MENTIONS "RV [RIGHT VENTRICLE] LEAD" ISSUES, WHICH ARE UNRELATED TO AN ULTRASONIC SCALER. LACK OF NOTIFICATION: WHILE THE FILING CLAIMS PARKELL WAS NOTIFIED ON (B)(6) 2026, THE COMPANY MAINTAINS THEY HAVE RECEIVED NO SUCH COMMUNICATION. INAPPROPRIATE USE CASE: THE EVENT OCCURRED IN A HOSPITAL, A SETTING FOR WHICH PARKELL'S SCALERS ARE NOT RECOMMENDED. PARKELL'S ACTION PLAN: INVESTIGATION: THE COMPANY IS INVESTIGATING WHETHER A PARKELL DEVICE WAS ACTUALLY INVOLVED. RECOVERY: EFFORTS ARE UNDERWAY TO RECOVER THE SPECIFIC UNIT FOR TECHNICAL EVALUATION. REGULATORY COMPLIANCE: THIS FILING SERVES AS A PROACTIVE MEASURE WHILE THE COMPANY GATHERS FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 721892 | UNKNOWN | SCALER, ULTRASONIC | ELC | UNKNOWN | D410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male |