MAUDE Adverse Event Report: BECTON DICKINSON KIT TABLET; INTELLIPORT SYSTEM

Model Number	516704
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that there was a delay while using kit tablet.The following information was provided by the initial reporter: material no.516704, serial number.(b)(4).It is reported customer experienced delay in medication delivery.Verbiage received, tablet shutdown/ case #(b)(4): time 10:00 a.M.Sensor #(b)(4).Issues: crna was trying to add and confirm a dose(sugammadex) on tablet 3 and tablet 3 went to the screen saying the system is down and to contact the administrator.There was no yellow banner *gateway not connected.Allergies may not be current.Crna said that she did not disconnect the base from the sensor prior to this.Customer also said "it was the same screen for a while then i restarted the tablet to set up for the next case as it wasnt changing.After i restarted it went back to waiting for the case to begin.The second case after this incident went perfectly fine though.I did not restart the tablet this morning.
Event or Problem Description
It was reported that there was a delay while using kit tablet.The following information was provided by the initial reporter: material no.516704, serial number.By0f7z1 it is reported customer experienced delay in medication delivery.Verbiage received, - tablet shutdown case #094: time 10:00 a.M.Sensor #9254 issues: crna was trying to add and confirm a dose(sugammadex) on tablet 3 and tablet 3 went to the screen saying the system is down and to contact the administrator.There was no yellow banner *gateway not connected.Allergies may not be current.Crna said that she did not disconnect the base from the sensor prior to this.Customer also said "it was the same screen for a while then i restarted the tablet to set up for the next case as it wasn¿t changing.After i restarted it went back to ¿waiting for the case to begin¿.The second case after this incident went perfectly fine though.I did not restart the tablet this morning.
Additional Manufacturer Narrative
H6: investigation summary no photos or samples were received by our quality for evaluation.A device history record review found no non-conformances associated with this issue during production of this batch.During investigation, it was found that the movement of the tablets can contribute to the tablet user interface issues such as slow response, tablet ui application crashes, and tablet hardware issues.To mitigate the issues, it was advised to the customer to reboot the tablet after changing tablet positioning (e.G.Changing rooms).This issue has been monitored and it has been observed that the reboot of the tablets has been effective as the number of tablet issues has significantly decreased in frequency.

• Brand Name: KIT TABLET
• Common Device Name: INTELLIPORT SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11362776
• Report Number: 2243072-2021-00557
• Device Sequence Number: 10996551
• Product Code: PHC
• UDI-Device Identifier: 00382905167041
• UDI-Public: 00382905167041
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: Other
• Device Model Number: 516704
• Device Catalogue Number: 516704
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1