MAUDE Adverse Event Report: SENSORY MEDICAL INC CUBBY TECHNOLOGY HUB; BED PATIENT MONITOR

Model Number KIT10001

Device Problems Break (1069); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2022

Event Type  malfunction  

Event Description

In (b)(6) 2022, complainant contacted the firm to report an occurrence that happened previously around the (b)(6) 2022 timeframe.Specifically, complainant alleged that the user was able to access the inside of the tech hub and antenna wires therein by way of, or in association with, the tech hub faceplate.Complainant alleges that the user chewed and/or ingested some or all of the antenna wires.Complainant stated that the user, ".Is fine.Nothing happened, he is fine.".

Event Description

In (b)(6) 2022, complainant contacted the firm to report an occurrence that happened previously around the (b)(6)2022 timeframe.Specifically, complainant alleged that the user was able to access the inside of the tech hub and antenna wires therein by way of, or in association with, the tech hub faceplate.Complainant alleges that the user chewed and/or ingested some or all of the antenna wires.Complainant stated that the user, ".Is fine.Nothing happened, he is fine.".

• Brand Name: CUBBY TECHNOLOGY HUB
• Type of Device: BED PATIENT MONITOR
• Manufacturer (Section D): SENSORY MEDICAL INC; 1514 blake st.; ste., 200; denver 80202
• Manufacturer (Section G): SENSORY MEDICAL INC; 1514 blake st.; ste., 200; denver CO 80202
• Manufacturer Contact: caleb polley ; 1514 blake st.; ste., 200; denver, CO 80202 ; 8559642664
• MDR Report Key: 16000420
• MDR Text Key: 308147496
• Report Number: 3020824629-2022-00002
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510(K)-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: KIT10001
• Device Catalogue Number: KIT10001
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NO 21 USC 360I(F) ACTION
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic