LIFETRACE 30597226 CMS4305

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-09-10 for LIFETRACE 30597226 CMS4305 manufactured by Kendall- Ltp.

Event Text Entries

[699467] We have recently experienced problems with a variety of the ge medical corometrics fetal monitors where the recorders have stopped printing or the paper has torn. It was noticed that some of the paper used in the fetal monitors was slightly wider than normal and contributed to the recorder failure. Both samples of this paper are purchased from the same after market manufacturer. The vendor was contacted and requests samples for analysis. There is only a slight difference between the two paper sizes, about 3/32 inches or 2. 3 mm, so it is difficult to tell the two sizes apart. The paper slips into the recorder easily if it is the right size. However, with the incorrect size, it is pretty snug and difficult to remove. Use of the wider paper causes the paper to stop printing and there have been complaints that the paper tears. To address this issue internally, the packs that are wider than normal have been collected.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number925767
MDR Report Key925767
Date Received2007-09-10
Date of Report2007-09-10
Date of Event2007-09-06
Report Date2007-09-10
Date Reported to FDA2007-09-10
Date Added to Maude2007-10-12
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameLIFETRACE
Generic NamePAPER, RECORDING
Product CodeDSF
Date Received2007-09-10
Returned To Mfg2007-09-10
Model Number30597226
Catalog NumberCMS4305
Lot Number*
ID Number*
OperatorNURSE
Device AvailabilityR
Device Age1 DY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key897674
ManufacturerKENDALL- LTP
Manufacturer AddressTWO LUDLOW PARK DRIVE CHICOPEE MA 01022 US

Device Sequence Number: 2

Brand NameCOROMETRICS
Generic NameFETAL MONITOR
Product CodeHGM
Date Received2007-09-10
Model Number118
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityR
Device Age9 YR
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key897675
ManufacturerGE MEDICAL SYSTEMS, LLC
Manufacturer Address3000 N GRANDVIEW BLVD. WAUKESHA WI 53188 US

Patients

Patient NumberTreatmentOutcomeDate
10 2007-09-10
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