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

Model Number	000002N
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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.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 or Problem Description
It was reported that the device was not reading the temperature nor recording the amount of output.
Event or Problem Description
It was reported that the device was not reading the temperature nor recording the amount of output.
Additional Manufacturer Narrative
The reported issue of the unit not recording the amount of output was confirmed.The root cause of the reported issue was isolated to the component u1 of the main pcb was not completely seated.This was causing the monitor to not operate properly.U1 was reseated and the monitor powered on and functioned.One battery door had a broken guide rail and clasp.The front enclosure had damage to the right arm mounting hub, the shoulder screw could not be tightened or loosened.The front enclosure was also broken on the bottom left base.Corrosion was found on the main pcb and it needed replaced; however, it was no longer available for this series of criticore.The criticore system identified in this record contained obsolete parts.The model no.And obsolete parts were covered under notice of discontinuance and obsolescence letter.The system could not be serviced, the repair order was canceled and the monitor would be return to the facility.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: "[1] customer owned and service pool units may be either 000002 n or ncm models.Manuals are not included in these units.Shipping carton may vary dependent upon model and date of manufacture.Baw0303254, rev:0 (pk0303254) (monitor label) states this is a class i, type bf continuous operation.".

• 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: 7842680
• Report Number: 1018233-2018-03930
• Device Sequence Number: 19225981
• Product Code: EXS
• UDI-Device Identifier: 00801741080777
• UDI-Public: (01)00801741080777
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/30/2018

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
• 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: 08/17/2018
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1