MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-13 for INTELLIVUE MX700 PATIENT MONITOR manufactured by Philips Medical Systems.
[57273247]
Patient Sequence No: 1, Text Type: N, H10
[57273248]
When ecg leads were removed from the patient the monitor went into asystole. No patient harm, nurse was in the room. Manufacturer response for pt. Monitor, philips (per site reporter): troubleshooting info/checked with clinical support for possible input.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6025507 |
| MDR Report Key | 6025507 |
| Date Received | 2016-10-13 |
| Date of Report | 2016-09-28 |
| Date of Event | 2016-09-27 |
| Report Date | 2016-09-28 |
| Date Reported to FDA | 2016-09-28 |
| Date Reported to Mfgr | 2016-09-28 |
| Date Added to Maude | 2016-10-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELLIVUE MX700 PATIENT MONITOR |
| Generic Name | CALCULATOR, PULMONARY FUNCTION DATA |
| Product Code | BZC |
| Date Received | 2016-10-13 |
| Model Number | MX700 |
| Catalog Number | MX700 |
| Operator | NURSE |
| Device Availability | * |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN RD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-13 |