DR2C CAPSULE ID: SW8-BSM-R/LOT #2013-27/22428S IC4752A-DR2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-15 for DR2C CAPSULE ID: SW8-BSM-R/LOT #2013-27/22428S IC4752A-DR2 manufactured by Given Imaging, Inc..

Event Text Entries

[16802024] Went to administer gi pill to pt for anemia. Physician notified that pt was on a telemetry unit and it is known that telemetry may interfere with pill capturing/recording. Physician said to go ahead with procedure. Pt attached to sensor belt and gi pill monitor/recorder. Recorder device would blink red, yellow, and blue at different times. Other endoscopy nurse called and came to look at device. Md called and notified of pill not recording correctly. Md ordered to d/c telemetry on patient and continue with procedure. Gi recording device was blinking blue correctly again and the gi pill was swallowed by the pt. Device was working properly when we left. Endoscopy unit was called by pt and md to inform that the monitor/recording device stopped working and was had no lights blinking anywhere on it. Rn called given rep and rep said to try switching out sensor belts. Rn went to pt's room, reinitialized/turned back on monitor/recording device and switched sensor belts. The monitoring device was not showing any lights/signals in the upper right hand area where the pill sensor is. Rn called rep again and was told to call given tech support. Called and spoke with tech support and was told to take another sensor belt up to the pt and called back when with the pt. Went back to pt's room with another sensor belt and called tech support again and was told to detach pt from monitor and take monitor back to the endoscopy center where the base/cradle is and to call tech support back again. Once back in the endoscopy center, called tech support again and followed the directions to trouble shoot. Was informed that monitor was not capturing correctly and pt would not be able to complete study due to malfunction of the recording device. Md and pt notified that procedure cannot be finished and may not have been recorded due to malfunction, pt told to call md's office tomorrow. Following tech support instructions, cd was burned of the gi pill study that did capture and sent to given tech support. All sensor belts were tested per tech support instructions and working properly. Recorder/monitoring device was removed, tagged, and given to cuc. Given tech support ticket # 300283272. Gi capsule id: sw8-bsm-r/lot #2013-27/22428s.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3596520
MDR Report Key3596520
Date Received2014-01-15
Date of Report2014-01-15
Date of Event2014-01-02
Report Date2014-01-15
Date Reported to FDA2014-01-15
Date Reported to Mfgr2014-01-29
Date Added to Maude2014-01-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 NameDR2C
Generic NameSYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE
Product CodeNSI
Date Received2014-01-15
Model NumberCAPSULE ID: SW8-BSM-R/LOT #2013-27/22428S
Catalog NumberIC4752A-DR2
Lot Number*
ID Number*
Device AvailabilityY
Device Age1 DA
Device Sequence No1
Device Event Key0
ManufacturerGIVEN IMAGING, INC.
Manufacturer Address3950 SHACKEFORD ROAD, SUITE 50 DULUTCH GA 30096 US 30096

Device Sequence Number: 2

Brand NamePILLCAM
Generic NameSYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
Product CodeNEZ
Date Received2014-01-15
Model NumberSW8-BSM-R
Catalog Number*
Lot Number2013-27/22428S
ID Number*
Device AvailabilityY
Device Age1 DAY
Device Sequence No2
Device Event Key0
ManufacturerGIVEN IMAGING, INC.
Manufacturer Address3950 SHACKEFORD ROAD, SUITE 50 DULUTCH GA 30096 US 30096


Patients

Patient NumberTreatmentOutcomeDate
10 2014-01-15

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