MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP
Report
- Report Number
- 3012307300-2022-02629
- Event Type
- Malfunction
- Date Received
- February 4, 2022
- Report Date
- February 4, 2022
- Manufacturer
- ST PAUL
- Product Code
- FRN
- UDI-DI
- 15019517069624
- PMA / PMN Number
- K111386
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
CUSTOMER REPORTED THAT THERE WAS A SYSTEM AUDIBLE ALARM FAILURE. BOTH SEAL ARE INTACT,TOP CASE CHIPPED ON LEFT CORNER, BOTTOM CASE CRACKED BY L-BRACKET, CRACKED RIGHT PLUNGER CASE. PERFORMED POWER UP PROCESS AND OCCLUSION TEST, PRIMARY AUDIBLE ALARM BGND TEST. UNABLE TO DETERMINE WHO CAUSED THE PROBLEM, FOUND NO DAMAGE TO SPEAKER OR INTERCONNECT BOARD. REPLACED SPEAKER AS A PREVENTATIVE MEASURE, PERFORMED ALL FUNCTIONAL TESTS WHICH IT PASSED.
CUSTOMER REPORTED THAT THERE WAS A SYSTEM AUDIBLE ALARM FAILURE. BOTH SEAL ARE INTACT,TOP CASE CHIPPED ON LEFT CORNER, BOTTOM CASE CRACKED BY L-BRACKET, CRACKED RIGHT PLUNGER CASE. PERFORMED POWER UP PROCESS AND OCCLUSION TEST, PRIMARY AUDIBLE ALARM BGND TEST. UNABLE TO DETERMINE WHO CAUSED THE PROBLEM, FOUND NO DAMAGE TO SPEAKER OR INTERCONNECT BOARD. REPLACED SPEAKER AS A PREVENTATIVE MEASURE, PERFORMED ALL FUNCTIONAL TESTS WHICH IT PASSED.
IT WAS REPORTED THAT THE DEVICE HAD SYSTEM AUDIBLE ALARM FAILURE AND BROKEN CASE. NO PATIENT INJURY WAS REPORTED.
IT WAS REPORTED THAT THE DEVICE HAD SYSTEM AUDIBLE ALARM FAILURE AND BROKEN CASE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1563026 | MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP | PUMPS, INFUSION | FRN | ST PAUL | 4000 | 15019517069624 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |