MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-26 for BARD? CRITICORE? MONITOR 000002N manufactured by Dymax Corp. -2523003.
[73910648]
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
[73910649]
It was reported the device was not reading correctly.
Patient Sequence No: 1, Text Type: D, B5
[86861940]
The reported issue of the unit is not reading correctly was unconfirmed. The criticore was visually inspected upon receipt and was found to be free of physical damage and/or defects and functions normally. The monitor powers on, and the warranty label is intact. The monitor functioned correctly. The unit measured the 0ml, 500ml and 2100ml containers correctly. All d cell batteries, the coin cell, and the battery door were replaced. The criticore was subsequently inspected and tested by (b)(4) in accordance with bes-dymax standard processes and procedures and was found to fully comply with all requirements and specifications. The unit was serviced and was working properly. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use 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 tables in section 9, emc compliance. Portable and mobile rf communications equipment may affect the criticore? Monitor. The criticore? Monitor may be interfered with by other equipment, even if that other equipment complies with cispr emission requirements. 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. Warning: during long-term storage, remove primary batteries. Warning: to avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth. Caution: do not set alarm limits to extreme values that can render the alarms useless. Caution: use only 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. Refer to section 6, maintenance for instructions on how to return the monitor to bard for service and/or calibration. 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 2012/19/eu on waste electronic and electrical equipment, july 4, 2012. Do not dispose with ordinary municipal waste. Caution: there are no serviceable components in the criticore? Monitor. The user and/or service personnel should not attempt repair of the criticore? Monitor. To do so, may void the warranty, and could result in erroneous monitor readings. Note: it is recommended that the monitor receive a maintenance inspection annually, including replacing the lithium coin cell, or more frequently as dictated by hospital protocol. The inspection must be performed at an authorized c. R. Bard, inc. Service facility. To arrange for service from c. R. Bard, inc. , call 1-800-526-4455. Note: always perform a functional checkout of the criticore? Monitor prior to putting the monitor into service after repair. " (b)(4). 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
[86861941]
It was reported the device was not reading correctly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-02116 |
| MDR Report Key | 6523410 |
| Date Received | 2017-04-26 |
| Date of Report | 2017-06-08 |
| Date Mfgr Received | 2017-05-30 |
| Device Manufacturer Date | 2015-07-01 |
| Date Added to Maude | 2017-04-26 |
| 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 | 3 |
| Brand Name | BARD? CRITICORE? MONITOR |
| Generic Name | CRITICORE MONITOR |
| Product Code | EXS |
| Date Received | 2017-04-26 |
| Returned To Mfg | 2017-04-17 |
| 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 | 2017-04-26 |