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