HUAM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-06 for HUAM * manufactured by *.

Event Text Entries

[33987] Monitor delivered to pt as replacement. Monitor alarmed "needs charging" inspite of being charged with a/c adapter for greater than 3 days. Monitor tested 8/96. End/outcome. Pt delivered pre-term.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 61240
• MDR Report Key: 61240
• Date Received: 1997-01-06
• Date of Report: 1996-08-26
• Date of Event: 1996-08-24
• Date Added to Maude: 1997-01-10
• 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: 3
• Initial Report to FDA: 3
• 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: HUAM
• Generic Name: UTERINE MONITOR
• Product Code: HFM
• Date Received: 1997-01-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 61608
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	1997-01-06