HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER
Report
- Report Number
- 3011137372-2016-00038
- Event Type
- Malfunction
- Date Received
- March 4, 2016
- Date of Event
- February 11, 2016
- Report Date
- February 12, 2016
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- RESPIRATORY THERAPIST
- Health Professional
- N
Narratives
(B)(4). THE SAMPLE WAS RETURNED TO THE SUPPLIER FOR INVESTIGATION. THE INVESTIGATION RESULTS ARE AS FOLLOWS: THE DUCKBILL VALVE WAS ATTACHED TO THE BOTTOM CAP OF THE NRV AND THE PORT WAS OPENED. THE BAG CANNOT BE PRESSED AND THE AIR IN THE BAG CANNOT EXHALE. THE PATIENT CONNECTOR OF THE DEFECTIVE SAMPLE WAS INSERTED INTO THE CAP. THE WHITE CAP WAS REMOVED. THE RING CAME OFF AND THE CONNECTOR WAS PRESSED DEEPLY INTO THE HOLE. THAT CAUSED THE DUCKBILL VALVE TO BE DEFORMED AND BLOCKED BY THE BOTTOM CAP OF NRV. 100% LEAKAGE TESTS ARE GIVEN TO THE PRODUCTS AT RESUSCITATOR ASSEMBLY LINE. THE BAGS ARE PRESSED AND WHEN THE PRESSURE REACHES 70 CMH2O, THE PRESSURE SHALL NOT FALL WITHIN 3 SECONDS. THE RETURNED SAMPLE CANNOT BE PRESSED AND THE PRESSURE CANNOT RISE TO 70CMH2O. THIS DEFECT CAN BE DETECTED BY LEAKAGE TESTER. CONCLUSION: THE RESUSCITATOR WAS HIT BY SUDDEN FORCE AND THE CONNECTOR WAS PRESSED INTO THE NVR. THAT CAUSED THE DUCKBILL VALVE TO BE BLOCKED BY THE BOTTOM CAP AND THE AIR CANNOT EXHALE. THIS DEFECT HAPPENED DURING TRANSPORTATION AND IT WAS CONSIDERED TO BE A SINGLE CASE. OTHER REMARKS: A CONCLUSION CODE COULD NOT BE FOUND.
(B)(4). A DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE DEVICE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.
THE CUSTOMER ALLEGES THAT THE RESUSCITATION EXHALATION VALVE FAILED. THE BAG DID NOT ALLOW EXHALED AIR TO PASS. THE CLINICIANS COULD NOT VENTILATE AND HAD TO GET ANOTHER BAG. DURING THIS TIME THEY EXTUBATED THE PATIENT THEN REINTUBATED. ANOTHER BAG WAS USED AND THERE WERE NO PROBLEMS VENTILATING. THE PATIENT WAS PLACED ON THE VENTILATOR. THE PATIENT LATER DIED DUE TO ILLNESS AND NOT TO RESUSCITATION BAG INCIDENT.
THE CUSTOMER ALLEGES THAT THE RESUSCITATION EXHALATION VALVE FAILED. THE BAG DID NOT ALLOW EXHALED AIR TO PASS. THE CLINICIANS COULD NOT VENTILATE AND HAD TO GET ANOTHER BAG. DURING THIS TIME THEY EXTUBATED THE PATIENT THEN REINTUBATED. ANOTHER BAG WAS USED AND THERE WERE NO PROBLEMS VENTILATING. THE PATIENT WAS PLACED ON THE VENTILATOR. THE PATIENT LATER DIED DUE TO ILLNESS AND NOT TO RESUSCITATION BAG INCIDENT.
QN#(B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. A PHONE CONVERSATION WAS CONDUCTED WITH RISK MANAGEMENT ((B)(4)) FROM THE USER FACILITY AND (B)(4) FROM TELEFLEX. MS (B)(4) CONFIRMS THAT THE PATIENT'S DEATH WAS NOT THE RESULT OF THE INCIDENT WITH THE RESUSCITATION BAG. THIS CONFIRMATION WAS STATED BY THE ED TEAM WHICH INCLUDED THE PHYSICIAN, RESPIRATORY THERAPIST AND NURSES. IT IS REPORTED, BY MS (B)(4), THAT THE PATIENT WAS PRESENTED TO THE ED DEPARTMENT IN NEAR RESPIRATORY ARREST.
THE CUSTOMER ALLEGES THAT THE RESUSCITATION EXHALATION VALVE FAILED. THE BAG DID NOT ALLOW EXHALED AIR TO PASS. THE CLINICIANS COULD NOT VENTILATE AND HAD TO GET ANOTHER BAG. DURING THIS TIME THEY EXTUBATED THE PATIENT THEN REINTUBATED. ANOTHER BAG WAS USED AND THERE WERE NO PROBLEMS VENTILATING. THE PATIENT WAS PLACED ON THE VENTILATOR. THE PATIENT LATER DIED DUE TO ILLNESS AND NOT TO RESUSCITATION BAG INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136849 | HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER | MANUAL EMERGENCY RESUSCITATOR | BTM | TELEFLEX MEDICAL | 1443 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | VENTILATOR| VENTILATOR| VENTILATOR |