| Brand Name | INTELLIVUE MP5 |
| Common Device Name | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) |
| Manufacturer (Section D) |
| PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| hewlett-packard-str. 2, |
| b1-3/d6 |
| boblingen 71034 |
| GM 71034 |
|
| Manufacturer (Section G) |
| PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| hewlett-packard-str. 2, |
| b1-3/d6 |
| boblingen 71034 |
|
GM
71034
|
|
| Manufacturer Contact |
|
hauke
schik
|
| hewlett-packard-str. 2, |
| b1-3/d6 |
| boblingen 71034
|
|
GM
71034
|
|
70314632031
|
|
| MDR Report Key | 24128688 |
| Report Number | 9610816-2026-100109 |
| Device Sequence Number | 16049242 |
| Product Code |
MHX
|
| UDI-Device Identifier | 00884838000230 |
| UDI-Public | (01)00884838000230 |
| Combination Product (Y/N) | N |
| Initial Reporter Country | CH |
| PMA/510(K) Number | K150310 |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Serviced by Third Party (Y/N) | N |
| Reporter Type |
Manufacturer
|
| Report Source |
Foreign,User Facility |
| Initial Reporter Occupation |
Other
|
| Type of Report
| Initial |
| Report Date (Section B) |
01/21/2026 |
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Is this an Adverse Event Report? |
No
|
| Is this a Product Problem Report? |
Yes
|
| Device Model Number | INTELLIVUE MP5 |
| Device Catalogue Number | 865024 |
| Was Device Available for Evaluation? |
No
|
| Type of Report(Section G) | Thirty-Day |
| Initial Date Received by Manufacturer | 12/23/2025 |
| Initial Report FDA Received Date | 01/21/2026 |
| Was Device Evaluated by Manufacturer? (Y/N) |
No
|
| Date Device Manufactured | 10/31/2018 |
| Is the Device Labeled for Single Use? (Y/N) |
No
|
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N) |
No
|
| Usage of Device |
Reuse
|
| Patient Sequence Number | 1 |
| Patient Sex | Unknown |
|
|