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

Model Number	000002N
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the criticore device was not registering the correct temperature.The temperature was off by 10 degrees.
Event or Problem Description
It was reported that the criticore device was not registering the correct temperature.The temperature was off by 10 degrees.
Additional Manufacturer Narrative
The reported problem was unconfirmed.The root cause could not be determined due to the inability to reproduce the reported issue.The handle was broken and one handle cover was missing.The left hook was bent.The monitor would not power on because the coin cell measured 2.823vdc which was less than the 3.00vdc minimum operating voltage.The coin cell battery was replaced due to low voltage.The adhesive was removed from the face shield.The handle was replaced and a new handle cover was installed.The left hook was replaced.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." 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.

• Brand Name: BARD® CRITICORE® MONITOR
• Common Device Name: CRITICORE MONITOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8311188
• Report Number: 1018233-2019-00664
• Device Sequence Number: 11138199
• Product Code: EXS
• UDI-Device Identifier: 00801741080777
• UDI-Public: (01)00801741080777
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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
• Operator of Device: Health Professional
• Device Model Number: 000002N
• Device Catalogue Number: 000002N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1