* ADAPTER M1347A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-02-09 for * ADAPTER M1347A manufactured by Agilent Technologies.

Event Text Entries

[197788] Add'l info rec'd from mfr 3/20/01: in 12/00, agilent initiated a voluntary recall for the safeconnect decg adapter model m1347a after receiving reports of loss of decg signal, which may have been due to poor electrical connection may cause loss of or interference with the decg signal. Agilent notified the food and drug administration of this recall on 12/8/01. Agilent has not yet received notice that the recall has been classified by cdrh or assigned a z number. The safeconnect decg adapter model m1347a was modified by increasing the spacing between the adapter contacts so that they press more tightly against the contacts of the mating part on the leg plate, and by adding a lengthwise bend to the adapter contacts so that two sharp edges are presented to the mating part rather a large flat surface.
Patient Sequence No: 1, Text Type: D, B5

[225151] There were problems with the use of the cable and adapter used with fetal scalp electrodes - either intermittent or absent signals. Pt's fetal heart tones were intermittent and absent throughout the monitoring process. Since this event, the co supplied an equipment upgrade as this hosp was not included in the recall process. (the hosp was using the equipment not knowing there was a problem).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1021055
• MDR Report Key: 316015
• Date Received: 2001-02-09
• Date of Report: 2001-02-07
• Date of Event: 2001-01-04
• Date Added to Maude: 2001-02-16
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: *
• Generic Name: FETAL MONITORING/SCALP ELECTRODE
• Product Code: KXN
• Date Received: 2001-02-09
• Returned To Mfg: 2001-01-10
• Model Number: ADAPTER M1347A
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 305572
• Manufacturer: AGILENT TECHNOLOGIES
• Manufacturer Address: 3000 MINUTE MAN RD, MS0400 ANDOVER MA 01810 US

Device Sequence Number: 2

• Brand Name: *
• Generic Name: FETAL MONITORING/SCALP ELECTRODE
• Product Code: HGP
• Date Received: 2001-02-09
• Returned To Mfg: 2001-01-10
• Model Number: MONITOR 1350B
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 305574
• Manufacturer: AGILENT TECHNOLOGIES
• Manufacturer Address: 3000 MINUTE MAN RD, MS0400 ANDOVER MA 01810 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2001-02-09