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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARESTREAM HEALTH, INC. DRX-1 TRANSPORTABLE SYSTEM; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
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CARESTREAM HEALTH, INC. DRX-1 TRANSPORTABLE SYSTEM; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Back to Search Results
Model Number DRX-1
Device Problem Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/18/2019
Event Type  malfunction  
Event Description
"multiple batteries received (model drx-1 system battery) have become defective in a short amount of time.The manufacturer provides a 14-month warranty but many do not make it that far.Replacements have been failing as well.They don't simply lose battery capacity or diminish in life, they just stop charging/working.The failure is abrupt with no symptoms or warning beforehand.It may be possible this can happen while performing an exam causing a patient to be radiated with no resulting image." by radiology director.We have about 29 of these batteries and they are all about 1 year old and half of them have already been replaced.Manufacturer response for drx-1 system battery, carestream (per site reporter).The battery is under warranty, so they just replace it and don't acknowledge that there may be an issue.
 
Event Description
"multiple batteries received (model drx-1 system battery) have become defective in a short amount of time.The manufacturer provides a 14-month warranty but many do not make it that far.Replacements have been failing as well.They don't simply lose battery capacity or diminish in life, they just stop charging/working.The failure is abrupt with no symptoms or warning beforehand.It may be possible this can happen while performing an exam causing a patient to be radiated with no resulting image." by radiology director we have about 29 of these batteries and they are all about 1 year old and half of them have already been replaced.These batteries are being used on drx plus dr detectors that were manufactured february, june and september 2018.The battery models are mainly the ¿drx-1 system battery¿, but also ¿drx-bat2¿ and ¿drx-bat3¿ model batteries gave us issues as well.The oem provided battery charges that are specific to their batteries.It has been noted that some users with some devices are leaving batteries on the charging units for long periods of time which can impact battery life.Our normal routine is to swap out batteries once they reach around 30-50% to avoid disruption in patient care during exams.We rarely, if ever, fully discharge a battery in one day.We have enough batteries to place a fully charged battery once one gets below half.The detector batteries are swapped about 2 times per day but never go to 0% to 100% during a charge.We don¿t see any error messages are warnings prior to failure.Periodically we check the health of the system and batteries and haven¿t noted anything prior to failure as it¿s usually abrupt.Manufacturer response for drx-1 system battery, carestream (per site reporter).The battery is under warranty, so they just replace it and don't acknowledge that there may be an issue.
 
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Brand Name
DRX-1 TRANSPORTABLE SYSTEM
Type of Device
SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Manufacturer (Section D)
CARESTREAM HEALTH, INC.
1049 west ridge road
rochester NY 14615
MDR Report Key9144771
MDR Text Key160851999
Report Number9144771
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 09/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberDRX-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2019
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/24/2019
Device Age8 MO
Event Location Hospital
Date Report to Manufacturer10/02/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/02/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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