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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER XPRT; LOW AIR LOSS PULMONARY BED
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STRYKER XPRT; LOW AIR LOSS PULMONARY BED Back to Search Results
Device Problems Circuit Failure (1089); Inflation Problem (1310); Overheating of Device (1437)
Patient Problem Pressure Sores (2326)
Event Date 01/21/2016
Event Type  Injury  
Event Description
Patient was on stryker xrt low air loss bed.Noted on this date that mattress was not inflating, though bed mechanicals (head and foot of bed, etc.) were functional.Removed bed from service and patient was transferred to a low air loss bariatric bed.Upon evaluation it was noted that bed circuitry was not functional; it appeared that circuitry had overheated.Mfr rep conveyed that devices plugged into the bed's power outlets (i.E., infusion pumps, sequential pneumatic pumps) could not exceed 3 amps.Because of the overampage on the circuit board, there was no alarm indicating that the support surface was no longer functional.Beds were subsequently labeled to reflect the requirement of having no more than 3 amps plugged into the bed.Patient on non-functional surface developed pressure ulcer.
 
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Brand Name
XPRT
Type of Device
LOW AIR LOSS PULMONARY BED
Manufacturer (Section D)
STRYKER
MDR Report Key5546889
MDR Text Key41943056
Report NumberMW5061465
Device Sequence Number1
Product Code INX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/31/2016
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 Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/31/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age58 YR
Patient Weight88
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