MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2019-03-28 for BARD? CRITICORE? MONITOR 000002N manufactured by C.r. Bard, Inc. (covington) -1018233.
[140548485]
The reported issue was confirmed. The root cause of the reported issue was isolated to a calibration issue. The temperature reading was calibrated. The monitor passed all tests and is functioning properly and ready for use. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use were found adequate and state the following: "warning: the criticore monitor requires special precautions regarding emc and needs to be installed and put into service according to the emc information provided in the following tables. Portable and mobile rf communications equipment may affect the criticore monitor. Warning: the criticore monitor should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the criticore monitor should be observed to verify normal operation in the configuration in which it will be used. Warning: do not immerse or submerge the monitor or turn it upside down when cleaning. Caution: use only heavy-duty alkaline d cell batteries. Do not use rechargeable batteries. Do not incinerate batteries. Recycle or dispose of them properly. Contact bard for disposal information. Caution: improper orientation of the batteries within the battery pack can potentially damage the criticore monitor. Caution: state and federal regulations govern the packaging necessary for return of medical product which may have been contaminated. Refer to local, state and federal regulations when packaging the criticore monitor for return. Caution: there are no user serviceable components inside the criticore monitor. The user should not attempt to repair the criticore monitor. To do so may void the warranty and could result in erroneous monitor readings. Caution: use of cables or sensors other than those specified for use with the criticore monitor, except those sold by bard for use as replacement part or repair components, may result in increased emissions or decreased immunity of the criticore monitor. Caution: the criticore monitor should be recycled properly per european union directive 2002/96/ec on waste electronic and electrical equipment, january 27, 2003. Do not dispose with ordinary municipal waste. "
Patient Sequence No: 1, Text Type: N, H10
[140548486]
Per completion of the investigation, it was found that the observed measured temperature was reading low when the test temperature plug was used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2019-01613 |
| MDR Report Key | 8461640 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2019-03-28 |
| Date of Report | 2019-04-01 |
| Date Mfgr Received | 2019-03-15 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2019-03-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD? CRITICORE? MONITOR |
| Generic Name | CRITICORE MONITOR |
| Product Code | EXS |
| Date Received | 2019-03-28 |
| Returned To Mfg | 2019-02-12 |
| Model Number | 000002N |
| 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 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-28 |