FDA Adverse Event Malfunction Summary report: N

CALEO INCUBATOR, INFANT

MDR report key: 5055873 · Received September 4, 2015

Report

Report Number
5055873
Event Type
Malfunction
Date Received
September 4, 2015
Date of Event
August 13, 2015
Report Date
September 3, 2015
Manufacturer
DRAEGER MEDICAL GMBH
Product Code
FMZ
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
MN, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ON MONDAY, A BIOMED TECH WAS IN THE NEONATAL INTENSIVE CARE UNIT (NICU), AND A NURSE MENTIONED AN ODOR TO HIM. THE BIOMED TECH COULD NOT SMELL ANYTHING SO IT WAS EITHER A FAINT OR INTERMITTENT ODOR. THREE DAYS LATER, THE DATE OF THE INCIDENT, MAINTENANCE RECEIVED TWO PHONE CALLS FROM NICU, BOTH CALL WERE FROM NICU NURSES STATING THERE WAS A WEIRD ODOR COMING FROM THE VENTS. THE FIRST CALL WAS AT 11:15 A.M. AND THE NURSE SAID THE ODOR WAS PRESENT ON THE PREVIOUS DAY ALSO. THE SECOND CALL WAS AT 11:45 A.M. A MAINTENANCE ENGINEER RESPONDED AND COULD NOT SMELL ANYTHING. MAINTENANCE WAS UNABLE TO DETECT THE SOURCE OF THE ODOR. AT APPROXIMATELY 2:14 P.M., A NICU STAFF MEMBER SAW A FLAME APPROXIMATELY 12-18 INCHES HIGH COMING FROM AN OUTLET BEHIND A PATIENT'S INCUBATOR. THE NURSE ALERTED STAFF BY YELLING, "FIRE!" ANOTHER STAFF MEMBER CAME TO THE BEDSIDE, BEGAN PULLING OUT ELECTRICAL PLUGS FROM THE RED WALL OUTLET, AND DISCONNECTED THE CPAP. OTHER STAFF MEMBERS PULLED THE FIRE PANEL AND CALLED THE HOSPITAL'S EMERGENCY PHONE NUMBER TO REPORT THE FIRE. ANOTHER STAFF MEMBER DEPLOYED A FIRE EXTINGUISHER AND SUCCESSFULLY EXTINGUISHED THE ONE-FOOT TALL FLAMES COMING FROM THE RED OUTLET. NO FURTHER FLAMES WERE NOTED. IMMEDIATELY, STAFF BEGAN TO MOVE THE PATIENTS OUT OF THIS NICU NURSERY INTO A SEPARATE, SECOND NICU NURSERY. THE NICU WAS EVACUATED IN THREE-TO-FIVE MINUTES. THE PLUG ON THE INCUBATOR'S POWER CORD WAS NOTED TO BE MELTED. THE INCUBATOR, AFFECTED POWER CORD, AND ALL OF THE OTHER EQUIPMENT USED IN THIS PATIENT'S CARE WERE REMOVED FROM THE NICU AND BROUGHT DIRECTLY TO THE BIOMED DEPARTMENT. THE PATIENT INVOLVED WAS PLACED IN A NEW INCUBATOR AND AN AMBU BAG WAS USED TO PROVIDE THE PATIENT WITH RESPIRATORY SUPPORT UNTIL A NEW CPAP MACHINE WAS READY TO BE USED. THERE WERE NO ADVERSE EFFECTS TO THIS PATIENT. INCIDENT MANAGEMENT WAS CONDUCTED, THE UNIT WAS CLEANED, AND THE PATIENTS WERE MOVED BACK TO THE NICU THREE DAYS AFTER THE EVENT. THERE WERE NO INJURIES TO ANY OF THE INVOLVED STAFF, PATIENTS OR FAMILY MEMBERS BECAUSE OF THIS EVENT. THE ROOT CAUSE, WHILE NOT CONFIRMED, APPEARS TO BE THAT THE INCUBATOR'S POWER CORD PLUG IS THE SOURCE. IN REGARDS TO THE ODOR THAT WAS PRESENT PRIOR TO THE EVENT, IT APPEARS THE ODOR MAY HAVE BEEN INTERMITTENT. WE ARE NOT SURE THE ODOR WAS COMING FROM THE POWER CORD OR SOMETHING ELSE, BUT WE HAVE NOT HAD ANY OTHER ODOR CALLS IN THE NICU AFTER THIS EVENT. BIOMED FOLLOW UP: THE PLUG END OF THE FELLER POWER CORD IDENTIFIED AS THE SOURCE OF THE FIRE WAS SIGNIFICANTLY DAMAGED. BIOMED REMOVED AND REPLACED LIKE-FELLER POWER CORDS FOUND ON THREE OTHER DRAEGER CALEO INCUBATORS IN THE HOSPITAL NICU. BIOMED VERIFIED THERE WERE NO OTHER LIKE-FELLER POWER CORDS BEING USED ON ANY OTHER MANUFACTURES' INCUBATORS BEING USED IN THE HOSPITAL NICU. THE LAST PM OF THE ISOLETTE WAS COMPLETED IN JULY 2015. THE CALEO INCUBATOR INVOLVED WAS EVALUATED AND TESTED BY BIOMED AFTER THE POWER CORD WAS REPLACED. THE INCUBATOR FUNCTIONED AND TESTED TO MANUFACTURE'S SPECIFICATIONS AND WAS RETURNED TO SERVICE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
587948 CALEO INCUBATOR, INFANT INCUBATOR, NEONATAL FMZ DRAEGER MEDICAL GMBH

Patients

Seq Age Sex Outcome Treatment
1 0 YR CALEO INCUBATOR WITH FELLER POWER CORD