MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® CRITICORE® MONITOR; CRITICORE MONITOR

Model Number 000002N

Device Problems Erratic or Intermittent Display (1182); Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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.".

Event Description

Per completion of the investigation, it was found that the observed measured temperature was reading low when the test temperature plug was used.

Event Description

Per completion of the investigation, it was found that the observed measured temperature was reading low when the test temperature plug was used.

Manufacturer Narrative

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 was functioning properly and ready for use.The investigation indicated that the reported issue was not manufacturing or supplier related.Therefore, a device history record review was not required.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.".

Manufacturer Narrative

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 was functioning properly and ready for use.The investigation indicated that the reported issue was not manufacturing or supplier related.Therefore, a device history record review was not required.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." section a through f - the information provided by bd 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 bd.

Event Description

Per completion of the investigation, it was found that the observed measured temperature was reading low when the test temperature plug was used.

• Brand Name: BARD® CRITICORE® MONITOR
• Type of Device: CRITICORE MONITOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8461640
• MDR Text Key: 140548485
• Report Number: 1018233-2019-01613
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741080777
• UDI-Public: (01)00801741080777
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000002N
• Device Catalogue Number: 000002N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: 03/06/2019; 03/15/2019
• Supplement Dates FDA Received: 03/29/2019; 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1