MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-28 for CRITICORE FLUID OUTPUT & CORE TEMPERATURE MONITORING SYSTEM - MONITOR 000002N manufactured by Dymax Corp. -2523003.
[71233613]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[71233614]
It was reported that the device' display screen continuously freezes. Additional information regarding this event has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-01364 |
| MDR Report Key | 6441505 |
| Date Received | 2017-03-28 |
| Date of Report | 2017-07-08 |
| Date Mfgr Received | 2017-06-24 |
| Device Manufacturer Date | 2007-05-01 |
| Date Added to Maude | 2017-03-28 |
| 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 | AMY GRAVLEY |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | DYMAX CORP. -2523003 |
| Manufacturer Street | 110 MARSHALL DRIVE |
| Manufacturer City | WARRENDALE PA 15086 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15086 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CRITICORE FLUID OUTPUT & CORE TEMPERATURE MONITORING SYSTEM - MONITOR |
| Generic Name | CRITICORE MONITOR |
| Product Code | EXS |
| Date Received | 2017-03-28 |
| Returned To Mfg | 2017-03-10 |
| Catalog Number | 000002N |
| 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 | DYMAX CORP. -2523003 |
| Manufacturer Address | 110 MARSHALL DRIVE WARRENDALE PA 15086 US 15086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-28 |