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

Model Number 000002N

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that the display was broken.Per sample receipt, no serial number was found on the device; however per follow up with the biomed on (b)(6) 2017, the serial number of the device was traced by the id# written on the device and determined to be (b)(4).

Manufacturer Narrative

The reported issue of the device missing the serial number was confirmed.The root cause of the reported event of the serial number missing could not be determined.Per follow up with the biomed on 11/29/2017, the serial number of the device was traced by the id# written on the device and determined to be (b)(4).The root cause of the reported issue in (b)(4) of the lcd display being broken could not be determined; however, the device is a portable unit and is susceptible to having damage done to the display, enclosure, handles and arm assemblies through using and positioning the device.This could also have attributed to the missing serial number.The display lcd was broken on the right side and it was replaced.The unit has been serviced and it is working properly.The serial number was added to the device.The device was returned to service.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).

Event Description

It was reported that the display was broken.Per sample receipt, no serial number was found on the device; however per follow up with the biomed on 11/29/2017, the serial number of the device was traced by the id# written on the device and determined to be (b)(4).

• 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: 7130550
• MDR Text Key: 95527404
• Report Number: 1018233-2017-06392
• 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: other
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

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: Other
• Device Model Number: 000002N
• Device Catalogue Number: 000002N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 02/12/2018
• Supplement Dates FDA Received: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1