FDA Adverse Event
Malfunction
Summary report: N
PHILIPS INFORMATION CENTER
MDR report key: 3170886
·
Received June 5, 2013
Report
- Report Number
- 1218950-2013-02127
- Event Type
- Malfunction
- Date Received
- June 5, 2013
- Report Date
- May 10, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K011093
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE STOPPED PROVIDING AUDIBLE ALARMS AND REQUESTED INFORMATION ABOUT THE ORDERING OF A REPLACEMENT AUDIO CARD. IF THIS ISSUE WERE TO OCCUR AGAIN, THERE IS A POTENTIAL FOR A DELAYED RESPONSE TO A PT SINCE PRODUCT LABELING DOES NOT INDICATE THAT STAFF MUST VISUALLY MONITOR THE DEVICE DISPLAY AT ALL TIMES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249634 | PHILIPS INFORMATION CENTER | MHX, DRT | MHX | PHILIPS MEDICAL SYSTEMS | M3150B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |