MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-14 for INTELLIVUE PATIENT MONITOR MP30 manufactured by Philips Medical Systems.
[57483501]
Patient Sequence No: 1, Text Type: N, H10
[57483502]
Wrong vitals (bp) were being transmitted to emr. Spoke with philips, they had staff discharge old patient from monitor and cycle power, problem was then resolved. Manufacturer response for pt monitor, mp30 (per site reporter): service instructions - issue resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6030469 |
| MDR Report Key | 6030469 |
| Date Received | 2016-10-14 |
| Date of Report | 2016-09-28 |
| Date of Event | 2016-08-16 |
| Report Date | 2016-09-28 |
| Date Reported to FDA | 2016-09-28 |
| Date Reported to Mfgr | 2016-09-28 |
| Date Added to Maude | 2016-10-14 |
| 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 PATIENT MONITOR MP30 |
| Generic Name | CALCULATOR, PULMONARY FUNCTION DATA |
| Product Code | BZC |
| Date Received | 2016-10-14 |
| Model Number | MP30 |
| Catalog Number | MP30 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 6 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 | 2016-10-14 |