XT RADIOGRAPHIC SUSPENSION 2102424 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-08-19 for XT RADIOGRAPHIC SUSPENSION 2102424 NA manufactured by General Electric Medical Systems.

Event Text Entries

[157993] On 6/8/99, x-ray tube suspension on the first unit would not allow the tube head to travel all the way up. During troubleshooting, the tube head suddenly dropped approx fifteen inches. More troubleshooting revealed the cable mount to box #1 had become disconnected. It appeared that this mount is attached to box #1, #2 and #3 with 2 pins through the mount into the side wall of the box and secured with an "e" clip on each pin. However, one pin hole in box #1 is through a double wall portion of the box and the pin in that hole is too short for an "e" clip to be installed. Unit #2: was inspected by biomedical engineering techs and was found to be identical to unit #1. General electric (ge) cares was contacted early on 7/9/99. Ge svc techs arrived at 1000 hrs. Tech called ge on-line center and was told ge had first seen this problem in 8/96 and production of this type mount (pin & "e" clip was stopped on 8/9/96). He was also told that ge safety had checked this and said there was no significant risk. Rptr's bioengineering dept disagrees and called ge customer satisfaction to solve this. Ge medical systems supplied two xt radiographic suspensions with mounts secured to boxes with threaded devices instead of pins and "e" clips. These suspension clips were exchanged free of charge on 7/14/99. According to the engineer the firm acknowledged to him that the design of this system was flawed, accounting for the incident, and the firm has since reverted to their original means of fastening the unit. Rptr's quality assurance alert - the following actions are required: a. Forward this alert to those commands owning pre-1997 ge x-ray equipment that may have the deficient pin and "e" clip design on their xt radiographic suspensions. B. All pre-1997 ge x-ray equipment with xt radiographic suspensions should be used with caution to prevent injury to the technologist prior to inspection. C. Perform an inspection within 30 days of all ge t3480g suspensions manufactured before 8/96 for cable mount security. D. Contact ge customer svc within 15 days of inspection for replacement of all defective ge t3480g suspensions. E. Request that commands having the ge suspension with the pin and "e" clip design contact the point of contact.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4002556
MDR Report Key237650
Date Received1999-08-19
Date of Report1999-08-09
Date of Event1999-06-08
Date Added to Maude1999-08-31
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameXT RADIOGRAPHIC SUSPENSION
Generic NameRADIOGRAPHIC SUSPENSION
Product CodeIYB
Date Received1999-08-19
Model Number2102424
Catalog NumberNA
Lot NumberNI
ID Number6525NS
OperatorUNKNOWN
Device AvailabilityY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key230303
ManufacturerGENERAL ELECTRIC MEDICAL SYSTEMS
Manufacturer Address3000 N. GRANDVIEW BLVD. WAUKESHA WI 53188 US

Device Sequence Number: 2

Brand NameXT RADIOGRAPHIC SUSPENSION
Generic NameRADIOGRAPHIC SUSPENSION
Product CodeIYB
Date Received1999-08-19
Model Number2102424
Catalog NumberNA
Lot NumberNI
ID Number6525NS
OperatorUNKNOWN
Device AvailabilityY
Device Age*
Implant FlagN
Date RemovedA
Device Sequence No2
Device Event Key230306
ManufacturerGENERAL ELECTRIC MEDICAL SYSTEMS
Manufacturer Address3000 N. GRANDVIEW BLVD. WAUKESHA WI 53188 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1999-08-19

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