FDA Adverse Event
Injury
Summary report: N
DIGITAL DIAGNOST DUAL DETECTOR
MDR report key: 2854225
·
Received November 29, 2012
Report
- Report Number
- 3003768251-2012-00025
- Event Type
- Injury
- Date Received
- November 29, 2012
- Date of Event
- November 9, 2012
- Report Date
- November 9, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS GMBH DMC
- Product Code
- MQB
- PMA / PMN Number
- K982795
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE OPERATOR NEGLECTED TO MOVE THE CEILING SUSPENSION TO A PLACE IN THE X-RAY ROOM WHERE IT DOES NOT INTERFERE WITH PATIENTS OR OTHERS. THE INSTRUCTIONS FOR USE (IFU) EXPLICITLY STATES THAT IT IS THE OPERATOR'S RESPONSIBILITY TO ENSURE THAT THE UNUSED CEILING SUSPENSION IS PLACED WHERE IT CANNOT INTERFERE WITH THE USER, PATIENTS OR OTHERS. NO MALFUNCTION WAS IDENTIFIED, THE SYSTEM WORKS AS SPECIFIED. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A FAMILY MEMBER OF A PATIENT HIT HER HEAD AT THE ALPHA DRIVE ROTATION MOTOR, THE WOUND WAS CLOSED WITH STITCHES AND A TETANUS VACCINE WAS GIVEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIGITAL DIAGNOST DUAL DETECTOR | MQB, KPR | MQB | PHILIPS MEDICAL SYSTEMS GMBH DMC | 7102022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |