IW950 COSYCOT INFANT WARMER
Report
- Report Number
- 9611451-2012-00358
- Event Type
- Malfunction
- Date Received
- May 31, 2012
- Report Date
- May 2, 2012
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- FMT
- PMA / PMN Number
- K971695
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
(B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING MORE INFORMATION ON THE COMPLAINT DEVICE. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
(B)(4). METHOD: THE COMPLAINT DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4). THEREFORE, OUR EVALUATION IS BASED ON OUR KNOWLEDGE OF THE PRODUCT AND THE INFORMATION PROVIDED BY THE HOSPITAL. RESULTS: THE HOSPITAL REPORTED THAT THE WARMER HEAD OF AN INFANT WARMER UNIT WAS CRACKED AND SOME PARTS ON THE LOWER CASE WERE "BROWN". THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER REVEALED THAT CRACK AND CHIP DAMAGE WERE EVIDENT ON THE LOWER CASE NEAR THE LAMP AND HEAD CLIP AREA. CRACKED LINES WERE OBSERVED ON THE MIDDLE SECTION OF THE WARMER HEAD. DELAMINATION OF THE OUTER PLASTIC SHELL AND SURFACE CRAZING WERE ALSO EVIDENT ON SOME DAMAGED AREAS. THE HOSPITAL REPORTED THAT THEY USED SURFANIOS AS THE CLEANING AGENT FOR THE INFANT WARMER UNITS. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 040211. CONCLUSION: THE CRAZING AND CRACKING OF THE COMPLAINT WARMER HEADS ARE RELATED TO A KNOWN PROBLEM OF INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE POLYCARBONATE PLASTIC AND ACRYLIC COMPONENTS OF THE INFANT WARMER. THE CLEANING AGENT USED BY THE HOSPITAL (SURFANIOS) CONTAINS DIDECYLDIMETHYLAMMONIUM CHLORIDE, WHICH IS NOT RECOMMENDED BY FPH. WHEN THE HEATER HEAD BEGINS TO WARM UP DURING USE, A CHEMICAL REACTION WITH THE INCOMPATIBLE CLEANING SOLUTION RESULTS IN GRADUAL CRACKING AND CRAZING OF THE HEATER HEAD. CRAZING OR CRACKING USUALLY OCCURS AT THE AREAS WHERE INTERNAL STRESS HAS DEVELOPED DURING THE MOULDING OF THE HEAD CASE AND AGGRAVATION. THE INFANT WARMER SERVICE MANUAL FEATURES A DIAGRAM OF THE INFANT WARMER WHICH HIGHLIGHTS POLYCARBONATE AND ACRYLIC COMPONENTS AND STATES THE FOLLOWING: "CAUTION DO NOT CLEAN THE HIGHLIGHTED PLASTIC SURFACES WITH PROPRIETARY CLEANING PRODUCTS CONTAINING EITHER HYDROXIDES, HYPOCHLORITES, PEROXIDES, GLUTARALDEHYDE OR CLEANING PRODUCTS WITH A GREATER THAN 30% ALCOHOL BASE." "CAUTION THE CHEMICALS USED IN THESE PROPRIETARY CLEANING PRODUCTS MAY LEAD TO DISCOLOURATION, CRAZING AND EVENTUAL CRACKING OF THE HIGHLIGHTED PLASTIC SURFACES". AS PART OF CONTINUOUS IMPROVEMENT, WE HAVE SINCE REVISED OUR CLEANING INSTRUCTIONS TO RECOMMEND SPECIFIC PROPRIETARY CLEANING WIPES. FPH REGIONAL OFFICE IN (B)(4) HAS SENT THE INSTRUCTIONS FOR USE TO THE HOSPITAL, WHICH CONTAINS INSTRUCTIONS ON HOW TO CLEAN THE PRODUCT AND A LIST OF RECOMMENDED CLEANING AGENTS.
(B)(4). METHOD: THE COMPLAINT DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4). THEREFORE OUR EVALUATION IS BASED ON OUR KNOWLEDGE OF THE PRODUCT AND THE INFORMATION PROVIDED BY THE HOSPITAL. RESULTS: THE HOSPITAL REPORTED THAT THE WARMER HEAD OF 7 INFANT WARMER UNITS WERE CRACKED AND SOME PARTS ON THE LOWER CASE WERE "BROWN". THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER REVEALED THAT CRACK AND CHIP DAMAGE WERE EVIDENT ON THE LOWER CASE NEAR THE LAMP AND HEAD CLIP AREA. CRACKED LINES WERE OBSERVED ON THE MIDDLE SECTION OF THE WARMER HEAD. DELAMINATION OF THE OUTER PLASTIC SHELL AND SURFACE CRAZING WERE ALSO EVIDENT ON SOME DAMAGED AREAS. THE HOSPITAL REPORTED THAT THEY USED SURFANIOS AS THE CLEANING AGENT FOR THE INFANT WARMER UNITS. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 040211. CONCLUSION: THE CRAZING AND CRACKING OF THE COMPLAINT WARMER HEADS ARE RELATED TO A KNOWN PROBLEM OF INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE POLYCARBONATE PLASTIC AND ACRYLIC COMPONENTS OF THE INFANT WARMER. THE CLEANING AGENT USED BY THE HOSPITAL (SURFANIOS) CONTAINS DIDECYLDIMETHYLAMMONIUM CHLORIDE, WHICH IS NOT RECOMMENDED BY FPH. WHEN THE HEATER HEAD BEGINS TO WARM UP DURING USE, A CHEMICAL REACTION WITH THE INCOMPATIBLE CLEANING SOLUTION RESULTS IN GRADUAL CRACKING AND CRAZING OF THE HEATER HEAD. CRAZING OR CRACKING USUALLY OCCURS AT THE AREAS WHERE INTERNAL STRESS HAS DEVELOPED DURING THE MOULDING OF THE HEAD CASE AND AGGRAVATION. THE INFANT WARMER SERVICE MANUAL FEATURES A DIAGRAM OF THE INFANT WARMER WHICH HIGHLIGHTS POLYCARBONATE AND ACRYLIC COMPONENTS AND STATES THE FOLLOWING: "CAUTION DO NOT CLEAN THE HIGHLIGHTED PLASTIC SURFACES WITH PROPRIETARY CLEANING PRODUCTS CONTAINING EITHER HYDROXIDES, HYPOCHLORITES, PEROXIDES, GLUTARALDEHYDE OR CLEANING PRODUCTS WITH A GREATER THAN 30% ALCOHOL BASE." "CAUTION THE CHEMICALS USED IN THESE PROPRIETARY CLEANING PRODUCTS MAY LEAD TO DISCOLOURATION, CRAZING AND EVENTUAL CRACKING OF THE HIGHLIGHTED PLASTIC SURFACES". AS PART OF CONTINUOUS IMPROVEMENT, WE HAVE SINCE REVISED OUR CLEANING INSTRUCTIONS TO RECOMMEND SPECIFIC PROPRIETARY CLEANING WIPES. FPH REGIONAL OFFICE IN (B)(4) HAS SENT THE INSTRUCTIONS FOR USE TO THE HOSPITAL, WHICH CONTAINS INSTRUCTIONS ON HOW TO CLEAN THE PRODUCT AND A LIST OF RECOMMENDED CLEANING AGENTS.
A HOSPITAL IN (B)(6) REPORTED VIA A FPH FIELD REPRESENTATIVE THAT AN IW950 INFANT WARMER COSYCOT HAD A CRACKED HEAD CASE, AND PARTS ON THE LOWER CASE WERE "BROWN". NO PATIENT CONSEQUENCE WAS REPORTED.
A HOSPITAL IN (B)(6) REPORTED VIA A FPH FIELD REPRESENTATIVE THAT AN IW950 INFANT WARMER COSYCOT HAD A CRACKED HEAD CASE, AND PARTS ON THE LOWER CASE WERE "BROWN". NO PATIENT CONSEQUENCE WAS REPORTED.
A HOSPITAL IN (B)(6) REPORTED VIA A FPH FIELD REPRESENTATIVE THAT AN IW950 INFANT WARMER COSYCOT HAD A CRACKED HEAD CASE, AND PARTS ON THE LOWER CASE WERE "BROWN". NO PATIENT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IW950 COSYCOT INFANT WARMER | FMT | FMT | FISHER & PAYKEL HEALTHCARE LTD | IW950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |