RESPIRATORY HUMIDIFIER
Report
- Report Number
- 9611451-2011-00764
- Event Type
- Injury
- Date Received
- December 8, 2011
- Date of Event
- August 26, 2011
- Report Date
- November 11, 2011
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BTT
- PMA / PMN Number
- K033710
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- OTHER
Narratives
(B)(4). METHOD: THE COMPLAINT DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) FOR INSPECTION. OUR INVESTIGATION IS BASED ON OUR KNOWLEDGE OF THE PRODUCT AND INFORMATION PROVIDED BY THE HOSPITAL. PHOTOGRAPHS OF THE COMPLAINT MR850 HUMIDIFIER, MR370 HUMIDIFICATION CHAMBER, TEMPERATURE PROBE AND BREATHING CIRCUIT USED WERE PROVIDED BY THE HOSPITAL. ADDITIONAL QUESTIONS WITH REGARD TO DEVICES, PATIENT AND SET UP WERE SENT TO THE HOSPITAL AND A RESPONSE WAS RECEIVED WITH LIMITED INFORMATION. RESULTS: A REVIEW OF THE PHOTOGRAPHS HAS IDENTIFIED THE FOLLOWING FPH PRODUCTS - MR850 RESPIRATORY HUMIDIFIER AND MR370 HUMIDIFICATION CHAMBER. ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL INDICATES THE HEATER WIRE ADAPTOR AND TEMPERATURE PROBE TO BE A FPH PRODUCT; HOWEVER, NO FURTHER INFORMATION WAS OBTAINED ABOUT THE REUSABLE HEATER WIRE USED. PHOTOGRAPHS PROVIDED BY THE HOSPITAL REVEALED THAT THE MR370 HUMIDIFICATION CHAMBER AND TEMPERATURE PROBE WERE MELTED AND BLACKENED. THE HOSPITAL STATED THAT THEY USED A REUSABLE BREATHING CIRCUIT, AND THE PHOTOGRAPHS REVEALED THAT THE BREATHING CIRCUIT USED IS A NON-FPH PRODUCT. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT 071210. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT COULD HAVE CAUSED THE INCIDENT REPORTED BY THE HOSPITAL AS NO COMPLAINT SAMPLE WAS RETURNED TO FPH FOR EVALUATION AND LIMITED INFORMATION WAS PROVIDED. WE WERE ABLE TO CONFIRM THAT THE REUSABLE BREATHING CIRCUIT USED BY THE HOSPITAL IS A NON-FPH PRODUCT, HOWEVER, IT WAS NOT POSSIBLE TO CONFIRM THE TYPE AND MANUFACTURER OF THE NON-FPH REUSABLE BREATHING CIRCUIT USED BY THE HOSPITAL. THE USER INSTRUCTIONS PROVIDED WITH THE MR850 HUMIDIFIERS STATE THE FOLLOWING: "THE USE OF BREATHING CIRCUITS, CHAMBERS OR OTHER ACCESSORIES WHICH ARE NOT APPROVED BY FISHER & PAYKEL HEALTHCARE MAY IMPAIR PERFORMANCE AND COMPROMISE SAFETY". THE HOSPITAL DID NOT PROVIDE US WITH DETAILED INFORMATION, WE ARE THEREFORE UNABLE TO PROVIDE DETAILS ON THE NATURE OF THE ALLEGED INJURY.
(B)(4). SUMMARY OF RESULTS: AS WE WERE NOT PROVIDED WITH THE COMPLETE INSPIRATORY TUBE OR THE HEATER WIRE, WE ARE UNABLE TO CONFIRM THE SOURCE OR CAUSE OF THE REPORTED FIRE. HOWEVER, FROM OUR INVESTIGATION OF THE COMPONENTS WE DID RECEIVE, WE DID NOT FIND ANY EVIDENCE TO SUGGEST THAT ANY FISHER & PAYKEL HEALTHCARE PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. METHOD: SINCE OUR LAST REPORT, FISHER & PAYKEL HEALTHCARE (B)(4) HAS RECEIVED SEVERAL COMPONENTS OF THE SET-UP FOR INSPECTION. OBSERVATIONS ON SET-UP: OUR UNDERSTANDING OF THE SET-UP IS BASED ON INFORMATION AND PHOTOS PROVIDED BY THE HOSPITAL, OUR INSPECTION OF THE COMPONENTS RETURNED, AND OUR KNOWLEDGE OF THE PRODUCTS. BASED ON THIS, WE UNDERSTAND THAT AN MR850 HUMIDIFIER (WITH AN MR370 CHAMBER) WAS CONNECTED TO A DRAGER EVITA XL VENTILATOR. A SIEMENS REUSABLE INSPIRATORY LIMB WAS CONNECTED BETWEEN THE MR370 CHAMBER AND A Y PIECE (FROM WHICH WE ASSUME A PATIENT INTERFACE WAS CONNECTED). AN FPH REUSABLE BREATHING TUBE WAS CONNECTED, AS PART OF THE EXPIRATORY LIMB, BETWEEN THE Y PIECE AND A PURITAN BENNETT WATER TRAP. FROM THE WATER TRAP, A SIEMENS REUSABLE BREATHING CIRCUIT FORMED THE SECOND (AND PRIMARY) PART OF THE EXPIRATORY LIMB. OBSERVATIONS ON COMPONENTS RECEIVED: THE FOLLOWING COMPONENTS WERE RECEIVED AND THE FOLLOWING OBSERVATIONS WERE MADE: A WHITE POWDERY SUBSTANCE WAS OBSERVED ON THE SURFACE OF THE RETURNED DEVICES. FPH MR850 RESPIRATORY HUMIDIFIER: THE MR850 DID NOT SHOW SIGNS OF HEAT OR BURN DAMAGE. THE MR850 PASSED ALL FUNCTIONAL CHECKS AND WAS TEST RUN FOR 24 HOURS WITH NO ERRORS. SOME BROKEN PIECES OF THE TEMPERATURE PROBE ADAPTOR WERE FOUND TO BE LODGED INSIDE THE TEMPERATURE PROBE SOCKET (SEE POINT 4 BELOW). THE EARTH WIRE OF THE MAINS CORD WAS FOUND TO BE DISCONNECTED FROM THE EARTH PIN OF THE MAINS PLUG. FPH MR370 REUSABLE CHAMBER: THE OUTLET PORT WAS MELTED AND CHARRED, CONSISTENT WITH DAMAGE OBSERVED IN CLOSE PROXIMITY TO INTENSE HEAT. THE ALUMINIUM SCROLL PRESENTED WITH BURN RESIDUE ON THE UPPER PART OF THE DOME. THE CHAMBER INLET PORT SHOWS NO SIGNS OF EXPOSURE TO HEAT. SIEMENS INSPIRATORY TUBE: ONLY PART OF THE INSPIRATORY TUBE WAS SENT TO US. THIS DISPLAYED BURN AND SMOKE DAMAGE. THE PART OF THE TUBE CLOSEST TO THE MR370 CHAMBER WAS MISSING. (B)(4) TEMPERATURE / FLOW PROBE: BURN DAMAGE WAS NOTED ON BOTH THE AIRWAY AND CHAMBER PROBES. THE PROBE CABLE WAS BLACKENED AND MELTED IN TWO AREAS ALONG ITS LENGTH AND A 40 MM AREA OF BURNT INSULATION WAS ALSO NOTED. THE REDEL PLUG AND PINS WERE ALSO FIRE DAMAGED. PART OF THE TEMPERATURE PROBE ADAPTOR WAS FOUND TO BE LODGED INSIDE THE TEMPERATURE SOCKET OF THE MR850 HUMIDIFIER. THIS IS CONSISTENT WITH IMPACT DAMAGE. NO HEAT DAMAGE WAS OBSERVED IN THIS AREA. (B)(4) HEATER WIRE PLUG: BURN DAMAGE WAS NOTICED ON THE HEATER WIRE PLUG. THE CABLE WAS FOUND TO BE PULLED FROM THE REDEL PLUG. (B)(4) Y-PIECE: SMOKE DAMAGE WAS OBSERVED ON AND IN THE Y-PIECE AND THE PRESSURE PORT CAP WAS MISSING. THIS IS CONSISTENT WITH DAMAGE THAT WOULD BE EXPECTED FROM A FIRE THAT STARTED ELSEWHERE IN THE SET-UP. FPH REUSABLE TUBE: SMOKE RESIDUE WAS OBSERVED IN AND ON THE TUBING. THIS IS CONSISTENT WITH DAMAGE THAT WOULD BE EXPECTED FROM A FIRE THAT STARTED ELSEWHERE IN THE SET-UP. PURITAN BENNET WATER TRAP: SMOKE DAMAGE AND CRACKS WERE OBSERVED ON THE COVER OF THE WATER TRAP. THIS IS CONSISTENT WITH DAMAGE THAT WOULD BE EXPECTED FROM A FIRE THAT STARTED ELSEWHERE IN THE SET-UP. SIEMENS EXPIRATORY TUBE: SMOKE DAMAGE WAS OBSERVED IN THE TUBING. THIS IS CONSISTENT WITH DAMAGE THAT WOULD BE EXPECTED FROM A FIRE THAT STARTED ELSEWHERE IN THE SET-UP. BURN DAMAGE WAS PRESENT ON THE EXTERIOR OF THE TUBE, CONSISTENT WITH OUR UNDERSTANDING, FROM PHOTOGRAPHS PROVIDED, THAT THIS EXPIRATORY TUBE WAS CONNECTED BACK INTO THE VENTILATOR AT A POINT ABOVE THE HUMIDIFIER AND CHAMBER. THE HEATER WIRE AND THE REMAINDER OF THE INSPIRATORY TUBE WERE NOT RETURNED TO US. WE WERE UNABLE TO CONFIRM THE MAKE OR MANUFACTURER OF THE HEATER WIRE. (B)(4): A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT 060216. MR850: A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT 071210. A LOT CHECK COULD NOT BE PERFORMED ON THE REMAINING FPH PRODUCTS AS NO LOT NUMBERS WERE PROVIDED. OBSERVATIONS ON THE SOURCE OF THE FIRE: THE ORIGIN OF A FIRE CAN USUALLY BE DETERMINED BY LOOKING FOR THE AREA IN WHICH THE GREATEST HEAT CONCENTRATION HAS OCCURRED. IN THIS CASE, THE DAMAGE OBSERVED INDICATES THAT THE FIRE BEGAN IN CLOSE PROXIMITY TO THE OUTLET PORT OF THE MR370. AS WE WERE NOT PROVIDED WITH THE COMPLETE INSPIRATORY TUBE (I.E. THE TUBE CONNECTED TO THE OUTLET PORT OF THE MR370 CHAMBER) OR THE HEATER WIRE, WE ARE UNABLE TO CONFIRM THE SOURCE OR CAUSE OF THE FIRE. HOWEVER, WE DID NOT SEE EVIDENCE TO SUGGEST THAT ANY OF THE FISHER & PAYKEL HEALTHCARE COMPONENTS WE DID RECEIVE (INCLUDING THOSE THAT APPEAR TO HAVE BEEN LOCATED IN CLOSE PROXIMITY TO THE OUTLET PORT) CAUSED OR CONTRIBUTED TO IGNITION. THE MR370 CHAMBER IS FILLED WITH WATER DURING OPERATION AND THERE IS NO IGNITION SOURCE PRESENT. THE HEATER WIRE PLUG AND THE PROBE ARE UNLIKELY TO HAVE BEEN THE SOURCE OF IGNITION AS THE PRODUCTS ARE INSULATED. (WE ALSO NOTE THAT WE HAVE NOT RECEIVED ANY COMPLAINTS OF THIS NATURE WHERE THE SOURCE OF IGNITION HAS BEEN THE HEATER WIRE PLUG, PROBE OR CHAMBER.) CONCLUSION: AS WE WERE NOT PROVIDED WITH THE COMPLETE INSPIRATORY TUBE OR THE HEATER WIRE, WE ARE UNABLE TO CONFIRM THE SOURCE OR CAUSE OF THE REPORTED FIRE. HOWEVER, FROM OUR INVESTIGATION OF THE COMPONENTS WE DID RECEIVE, WE DID NOT FIND ANY EVIDENCE TO SUGGEST THAT ANY FISHER & PAYKEL HEALTHCARE PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. OTHER COMMENTS: THE USER INSTRUCTIONS PROVIDED WITH THE MR850 HUMIDIFIER STATES THE FOLLOWING: "ENSURE MAINTENANCE OF GROUNDING INTEGRITY BY CONNECTION TO A "HOSPITAL GRADE" RECEPTACLE." "THE USE OF BREATHING CIRCUITS, CHAMBERS OR OTHER ACCESSORIES WHICH ARE NOT APPROVED BY FISHER & PAYKEL HEALTHCARE MAY IMPAIR PERFORMANCE AND COMPROMISE SAFETY." "CHECK ACCESSORIES FOR ANY PHYSICAL DAMAGE BEFORE USE AND REPLACE IF DAMAGED." WE HAVE NOT RECEIVED ANY FURTHER DETAILS ABOUT THE NATURE OF THE ALLEGED INJURY.
(B)(4). FISHER & PAYKEL HEALTHCARE HAS BEEN IN CONTACT WITH THE HOSPITAL AND ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION WITH REGARD TO THE EVENT, DEVICE SET UP, AND PATIENT STATUS. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
A HOSPITAL IN (B)(6) REPORTED TO DRAGER MEDICAL OF REGARDING AN INCIDENT IN WHICH A FIRE ALLEGEDLY OCCURRED IN AN UNSPECIFIED BREATHING CIRCUIT WITH A SET UP INVOLVING AN MR850 RESPIRATORY HUMIDIFIER, MR370 ADULT REUSABLE HUMIDIFICATION CHAMBER AND A DRAGER EVITA XL VENTILATOR. THE HOSPITAL HAS ALLEGED THAT THE INCIDENT "CAUSED RIGHT ARM FIRE INJURY" TO THE PATIENT.
A HOSPITAL IN THE (B)(6) REPORTED TO DRAGER MEDICAL OF REGARDING AN INCIDENT IN WHICH A FIRE ALLEGEDLY OCCURRED IN AN UNSPECIFIED BREATHING CIRCUIT WITH A SET UP INVOLVING AN MR850 RESPIRATORY HUMIDIFIER, MR370 ADULT REUSABLE HUMIDIFICATION CHAMBER AND A DRAGER EVITA XL VENTILATOR. THE HOSPITAL HAS ALLEGED THAT THE INCIDENT "CAUSED RIGHT ARM FIRE INJURY" TO THE PATIENT.
A HOSPITAL IN THE (B)(6) REPORTED TO DRAGER MEDICAL OF REGARDING AN INCIDENT IN WHICH A FIRE ALLEGEDLY OCCURRED IN AN UNSPECIFIED BREATHING CIRCUIT WITH A SET UP INVOLVING AN MR850 RESPIRATORY HUMIDIFIER, MR370 ADULT REUSABLE HUMIDIFICATION CHAMBER AND A DRAGER EVITA XL VENTILATOR. AT THIS STAGE, IT IS NOT KNOWN WHETHER THERE WAS ANY PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESPIRATORY HUMIDIFIER | BTT | BTT | FISHER & PAYKEL HEALTHCARE LTD | MR850 | 071210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4) ADULT REUSABLE HUMIDIFICATION CHAMBER| (B)(4) ADULT REUSABLE HUMIDIFICATION CHAMBER| DRAGER EVITA XL VENTILATOR| (B)(4) ADULT REUSABLE HUMIDIFICATION CHAMBER| DRAGER EVITA XL VENTILATOR| DRAGER EVITA XL VENTILATOR |