SMITHS MEDICAL PNEUPAC DISPOSABLE CIRCUITS
Received Sep 4, 2019 · Event occurred Jul 31, 2019
Report 3012307300-2019-04726 · MDR key 8962140
Device
Generic name
Accessory To Continuous Ventilator (respirator)
Catalog number
100/905/302
Lot number
161012
Product problems
- Device Alarm System
- Device Alarm System
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE FILE WAS INADVERTENTLY MARKED REPORTABLE. THE EVENT REPORTED UNDER MFR 3012307300-2019-04726-0049595 WAS DETERMINED TO BE NOT REPORTABLE AND NO FURTHER REPORTS WILL BE FILED USING THIS FILE NUMBER. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.
Additional Manufacturer Narrative
TWO UNOPENED AND ONE OPENED VENTILATOR CIRCUIT WERE RECEIVED AND INVESTIGATED BY THE SUPPLIER. VISUAL INSPECTION OF THE DEVICES FOUND THEM TO BE IN GOOD PHYSICAL CONDITION. THE OPENED CIRCUIT RECEIVED WAS ATTACHED TO A VENTILATOR AND SUBSEQUENTLY 35CMH2O BACK PRESSURE WAS APPLIED. THE UNIT FUNCTIONED CORRECTLY WITH NO HIGH PRESSURE ALARMS SOUNDING. THE REPORTED CUSTOMER COMPLAINT WAS NOT CONFIRMED.
Description of Event or Problem
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL VENTILATOR CIRCUIT WAS ALARMING HIGH PRESSURE, AS CIRCUIT WAS BLOCKED. INCIDENT OCCURRED PRIOR TO USE WITH A PATIENT. A NEW CIRCUIT WAS PLACED, AND DEVICE FUNCTIONED CORRECTLY AS A RESULT. NO PATIENT HARM RESULTED.