FDA Adverse Event
Other
Summary report: N
SPOT VITAL SIGNS
MDR report key: 1416708
·
Received May 15, 2009
Report
- Report Number
- 1316463-2009-00001
- Event Type
- Other
- Date Received
- May 15, 2009
- Date of Event
- March 1, 2009
- Report Date
- April 17, 2009
- Manufacturer
- WELCH ALLYN, INC.
- Product Code
- DXN
- PMA / PMN Number
- K002530
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON (B)(4) 2009 THE TRANSFORMER FROM THE DEVICE IS IN TRANSIT FROM THE (B)(4) TO WELCH ALLYN, INC. (B)(4). EXPECTED ARRIVAL IS (B)(4) 2009 UPON WHICH AN EVALUATION AND INVESTIGATION WILL BE CONDUCTED. A FOLLOW-UP TO THIS INITIAL REPORT WILL BE FILED AS SOON AS IT BECOMES AVAILABLE.
Description of Event or Problem · 1
WHEN CONNECTING THE DEVICE TO A MAIN POWER OUTLET, A STAFF NURSE (TS) RECEIVED AN ELECTRIC SHOCK AND SUFFERED ARM, HAND AND BACK PAIN AND A BURN TO THE LEFT PALM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPOT VITAL SIGNS | DXN | WELCH ALLYN, INC. | 42NTB-E4-M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |