UTERINE ASPIRATOR COMPACT 25 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-04-20 for UTERINE ASPIRATOR COMPACT 25 N/A manufactured by Ameda/egnell.

Event Text Entries

[442] Eggnell uterine aspirator was used to assist during vaginal delivery. It was used for approximately 1 hour along with fundal pressure. At birth, infant was noted to have sustained bleeding under scalp that required blood transfusion. Infant was transferred to dallas hospital for follow-up care. Device was evaluated and found to be operational within specificationsdevice not labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-mar-92. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: electrical tests performed, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: none or unknown. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: use of all similar devices stopped temporarily. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	447
MDR Report Key	447
Date Received	1992-04-20
Date of Report	1992-04-16
Date of Event	1992-04-07
Date Facility Aware	1992-04-07
Report Date	1992-04-16
Date Reported to FDA	1992-04-16
Date Reported to Mfgr	1992-04-16
Date Added to Maude	1992-04-29
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Health Professional	0
Initial Report to FDA	0
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	UTERINE ASPIRATOR
Generic Name	N/A
Product Code	HFC
Date Received	1992-04-20
Model Number	COMPACT 25
Catalog Number	N/A
Lot Number	N/A
ID Number	N/A
Operator	OTHER HEALTH CARE PROFESSIONAL
Device Availability	Y
Device Age	01-AUG-91
Implant Flag	N
Device Sequence No	1
Device Event Key	441
Manufacturer	AMEDA/EGNELL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-04-20