MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-04 for MONITOR,PHYSIOLOGICAL manufactured by Mckesson Horizon Cardiology.
[25007951]
Patient Sequence No: 1, Text Type: N, H10
[25007952]
During right heart catheterization in cath lab room one, we were not able to measure cardiac output, non-invasive blood pressure (nibp), or pulse oximetry.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5056383 |
| MDR Report Key | 5056383 |
| Date Received | 2015-09-04 |
| Date of Report | 2015-08-06 |
| Date of Event | 2015-05-15 |
| Report Date | 2015-07-28 |
| Date Reported to FDA | 2015-07-28 |
| Date Reported to Mfgr | 2015-07-28 |
| Date Added to Maude | 2015-09-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 |
| Generic Name | MONITOR,PHYSIOLOGICAL |
| Product Code | LNX |
| Date Received | 2015-09-04 |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MCKESSON HORIZON CARDIOLOGY |
| Manufacturer Address | 5995 WINDWARD PKWY. ALPHARETTA GA 30005 US 30005 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-04 |