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 Problems Vomiting (2144); Anxiety (2328); Distress (2329); Discomfort (2330); Foreign Body In Patient (2687); Unspecified Gastrointestinal Problem (4491)

Event Date 07/30/2022

Event Type  Injury  

Event Description

Complainant alleges that the patient chewed on, and swallowed, "some" of the tech hub radio antenna cable, and chewed on and swallowed some or all of the cord for the humidity / temperature sensor.This happened after the patient accessed the wires stowed inside the body of the assembled tech hub.This sequence of events led to a hospital er visit, x-rays, sedation, nasogastric tube, surgical consultation, and medication.During the er visit, the patient vomited, "which produced a couple of the electrical cords and a plastic tag." the patient was admitted to the hospital for observation and discharged after one (1) day.Per patient's caregiver (mother), there have been no complaints of abdominal pain.The family may have seen indication of the natural passage of a "tiny" wire but said they couldn't determine whether fuller passage has happened.Mother states that the family doesn't currently have any particular plans for additional visit(s) to a physician for further related treatment.

Manufacturer Narrative

None further.

• 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: 15650867
• MDR Text Key: 302192294
• Report Number: 3020824629-2022-00001
• Device Sequence Number: 1
• Product Code: KMI
• UDI-Device Identifier: 00860007550263
• UDI-Public: 860007550263
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• 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?: Yes
• Date Manufacturer Received: 07/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2022
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 11 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American