MITYVAC OB VACUUM PUMP PUMP #1- AG0067 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-10-20 for MITYVAC OB VACUUM PUMP PUMP #1- AG0067 * manufactured by Pristech, Inc..

Event Text Entries

[16756068] Vacuum cup applied to infant caput & attached to mityvac pump x2 using 2 separate pumps, to assist the fetal head to deliver. The gauges on both pumps were not registering properly. There was not enough vacuum. The pt was taken for a stat c-section. Infant apgars were 0^1-0^5-3^10-4^15.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 245784
• MDR Report Key: 245784
• Date Received: 1999-10-20
• Date of Report: 1999-10-14
• Date of Event: 1999-10-01
• Date Facility Aware: 1999-10-01
• Report Date: 1999-10-14
• Date Reported to FDA: 1999-10-14
• Date Reported to Mfgr: 1999-10-14
• Date Added to Maude: 1999-10-26
• 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
• Reporter Occupation: RISK MANAGER
• 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 Sequence Number: 1

• Brand Name: MITYVAC OB VACUUM PUMP
• Generic Name: VACUUM PUMP
• Product Code: FOD
• Date Received: 1999-10-20
• Model Number: PUMP #1- AG0067
• Catalog Number: *
• Lot Number: *
• ID Number: GAUGE#- 9217-02
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 238131
• Manufacturer: PRISTECH, INC.
• Manufacturer Address: PO BOX 725 RANCHO CUCAMONGA CA 917290725 US
• Baseline Brand Name: UMBILICAL CORD CLAMP
• Baseline Generic Name: UMBILICAL CORD CLAMP
• Baseline Model No: NA
• Baseline Catalog No: 6833-B
• Baseline ID: NA
• Baseline Device Family: UMBILICAL OCCLUSION DEVICE
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Device Sequence Number: 2

• Brand Name: MITYVAC OB VACUUM PUMP
• Generic Name: VACUUM PUMP
• Product Code: HDB
• Date Received: 1999-10-20
• Model Number: PUMP# 2- JF033
• Catalog Number: *
• Lot Number: *
• ID Number: GAUGE# 9217-02
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 238135
• Manufacturer: PRISTECH, INC.
• Manufacturer Address: PO BOX 725 RANCHO CUCAMONGA CA 917290725 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	1999-10-20