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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. TELEMETRY BOX; DETECTOR AND ALARM, ARRHYTHMIA
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SPACELABS HEALTHCARE INC. TELEMETRY BOX; DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Lot Number 2148
Device Problem Overheating of Device (1437)
Patient Problem Swelling (2091)
Event Date 08/19/2018
Event Type  malfunction  
Event Description
Staff went into the patient's room and noted that the telemetry box felt very hot.He changed the battery and the box remained hot.He notified the nurse of the event.The telemetry box was sent back to 3tele and a new one was placed on the patient.At that time, the patient did not have any redness to her skin.I received a call from staff and he notified me that he had a large red area on his hand and told me he thought it was from the tele box and that we should double check the patient's skin.I sent the primary nurse, into the room to check her skin.It was noted that she had developed a 3/4" blister below her breast.
 
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Brand Name
TELEMETRY BOX
Type of Device
DETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
SPACELABS HEALTHCARE INC.
spacelabs
35301 se center st
snoqualmie WA 98065
MDR Report Key7868019
MDR Text Key119944876
Report Number7868019
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot Number2148
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/22/2018
Event Location Hospital
Date Report to Manufacturer09/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age31390 DA
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