MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2019-11-05 for SENSICA UO MONITOR ICU SCCS1001 manufactured by Adaptec Medical Devices Llc 3014271001.
[179269653]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[179269674]
It was reported that the sensica device urine output was inaccurate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2019-07032 |
| MDR Report Key | 9279079 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2019-11-05 |
| Date of Report | 2020-03-03 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-02-01 |
| Date Added to Maude | 2019-11-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 |
| Manufacturer Contact | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | ADAPTEC MEDICAL DEVICES LLC 3014271001 |
| Manufacturer Street | 260 JAMES JACKSON AVENUE |
| Manufacturer City | CARY NC 27513 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27513 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSICA UO MONITOR ICU |
| Generic Name | SENSICA MONITOR |
| Product Code | EXS |
| Date Received | 2019-11-05 |
| Returned To Mfg | 2019-11-14 |
| Catalog Number | SCCS1001 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADAPTEC MEDICAL DEVICES LLC 3014271001 |
| Manufacturer Address | 260 JAMES JACKSON AVENUE CARY NC 27513 US 27513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-05 |