MalfunctionMOD
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Received Sep 17, 2020 · Event occurred Aug 27, 2020
Report 10546506 · MDR key 10546506
Device
Generic name
Orthopedic Manual Surgical Instrument
Product problems
- Crack
- Disconnection
Patient
Not reported
- Bradycardia
- Low Oxygen Saturation
- Bradycardia
- Low Oxygen Saturation
Narrative
Description of Event or Problem
PLASTIC PIECE THAT CONNECTS ENDOTRACHEAL TUBE TO VENTILATOR CIRCUIT AND JET VENTILATOR TUBING CRACKED, WITH CONNECTION TO JET TUBING NEARLY DISCONNECTED. REMOVED CRACKED PIECE AND REPLACED WITH INTACT CONNECTOR. PRIOR TO NOTING THIS CRACK, INFANT HAD FREQUENT BRADYCARDIA/DESATURATION EPISODES. AFTER REPLACING CONNECTOR, NOTED MARKED DECREASE IN INCIDENCE OF BRADYCARDIC EPISODES.