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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY TUBE
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SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY TUBE Back to Search Results
Model Number 60SP035
Medical Device Problem Codes Loose or Intermittent Connection (1371); Connection Problem (2900)
Health Effect - Clinical Codes Death (1802); Sudden Cardiac Death (2510)
Date of Event 12/17/2020
Type of Reportable Event Death
Event or Problem Description
It was reported that a device for measuring blood oxygen and heartbeat of a male infant patient issued an alarm.Immediately, a medical staff person found the issue (smiths medical the tube was disconnected) and gave life-saving medical care.The customer changed an emergency-use tube twice, but when he fed oxygen into the patient using the tube, it was not inserted into his trachea.2 hours later, the patient passed away.
 
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Brand Name
BIVONA
Common Device Name
TRACHEOSTOMY TUBE
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
5700 west 23rd ave
gary IN 46406
MDR Report Key11241941
Report Number3012307300-2021-00696
Device Sequence Number3563079
Product Code JOH
UDI-Device Identifier15021312000375
UDI-Public15021312000375
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K912469
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number60SP035
Device Catalogue Number60SP035
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/28/2020
Initial Report FDA Received Date01/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Death; Hospitalization; Other; Required Intervention;
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