STETHOSCOPE (NURSES) 30775-345

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-05 for STETHOSCOPE (NURSES) 30775-345 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[1210] Stethoscope was placed on top of radiant warmer. After the delivery of the baby, it was handed to the neonatalogist who examined the baby's chest with it. It was hot and burned the baby's skin. Left blister on left side of chestinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2031
MDR Report Key2031
Date Received1993-01-05
Date of Report1992-12-02
Report Date1992-12-02
Date Reported to FDA1992-12-02
Date Added to Maude1993-01-07
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 NameSTETHOSCOPE (NURSES)
Product CodeLDE
Date Received1993-01-05
Model Number30775-345
Catalog Number30775-345
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant Flag*
Device Sequence No1
Device Event Key1887
ManufacturerBAXTER HEALTHCARE CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1993-01-05

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