AIRSHIELDS C-300-2 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-06-11 for AIRSHIELDS C-300-2 UNKNOWN manufactured by Airshields, A Healthdyne Company.

Event Text Entries

[2749] Nurse lincoln had just returned from transporting an infant patient to nicu, and she plugged the empty unit in to recharge. A few minutes later smoke was discovered coming from the warmer. Upon inspection, it was discovered that flames were in evidence under the patient platform. The flames were subsequently extinguished with a co2 extinguisher. Once the flames were extinguished the transport incubator was turned over to cbet, of biomedical instrumentation. The following observations were made by biomedical instrumentation who inspected and evaluated the transport incubator. (see attached report). Device not labeled for single use. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-dec-92. Service provided by: user facility biomedical/bioengineering department. Invalid data - service records availability. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, mechanical tests performed, visual examination. Results of evaluation: component failure, electric problem - short circuit, insulation degradation/deterioration, material degradation/deterioration. Conclusion: device failure occurred and was related to event, device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service, use of all similar devices stopped temporarily, inserviced by biomedical engineering dept. Staff. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number5108
MDR Report Key5108
Date Received1993-06-11
Date of Report1993-05-27
Date of Event1993-05-15
Date Facility Aware1993-05-15
Report Date1993-05-27
Date Reported to Mfgr1993-05-15
Date Added to Maude1993-06-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameAIRSHIELDS
Generic NameINCUBATOR W/IN-HOUSE TRANSPORT CAPABILITY (RIGID-BASE)
Product CodeFPL
Date Received1993-06-11
Model NumberC-300-2
Catalog NumberUNKNOWN
Lot NumberNONE
ID NumberC/N 02-175-2965
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Device Age01-JAN-86
Implant FlagN
Device Sequence No1
Device Event Key4811
ManufacturerAIRSHIELDS, A HEALTHDYNE COMPANY


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1993-06-11

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