FDA Adverse Event
Malfunction
Summary report: N
MEDFUSION
MDR report key: 16210761
·
Received January 19, 2023
Report
- Report Number
- 3012307300-2023-00582
- Event Type
- Malfunction
- Date Received
- January 19, 2023
- Report Date
- May 3, 2023
- Manufacturer
- ST PAUL
- Product Code
- FRN
- UDI-DI
- 15019517069624
- PMA / PMN Number
- K111386
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
OTHER, OTHER TEXT: WHILE PERFORMING A REVIEW OF ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER, THERE WAS NO PATIENT INVOLVEMENT, THEREFORE, NO PATIENT DEATH, SERIOUS INJURY, AND NO EVIDENCE OF A REPORTABLE PRODUCT MALFUNCTION. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. FILE CC-0182151 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARDS ANY REPORTS ASSOCIATED WITH IT. JZINS.
Description of Event or Problem · 0
IT WAS REPORTED THE PUMP HAD A MOTOR ISSUE. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 369171 | MEDFUSION | PUMP, INFUSION | FRN | ST PAUL | 4000 | 15019517069624 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |