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

Model Number 000002N

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the screen on the monitor was frozen.

Manufacturer Narrative

The reported issue of the screen was frozen on the monitor was unconfirmed.The root cause of the reported issue could not be determined as the unit was inoperable at the time of the initial investigation.The reported issue was further investigated after the coin cell was replaced and the unit powered on.The unit was then operating normally.It was likely that the screen froze as a result of the coin cell voltage being below the 3.00vdc minimum operating voltage, although this could not be confirmed.Operation below the 3.00vdc minimum cannot be guaranteed.The unit has been serviced and is 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 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." (b)(4).

Event Description

It was reported that the screen on the monitor was frozen.

• 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
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 7045668
• MDR Text Key: 93065554
• Report Number: 1018233-2017-06011
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741080777
• UDI-Public: (01)00801741080777
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• 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: 11/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1