BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSP-50 THERMOSUIT PUMP CONTROLLER CONSOLE

    MDR report key: 24345778 · Received February 16, 2026

    Report

    Report Number
    3006059109-2026-00001
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    December 4, 2024
    Report Date
    February 12, 2026
    Manufacturer
    LIFE RECOVERY SYSTEMS
    Product Code
    NZE
    UDI-DI
    00851936007003
    PMA / PMN Number
    K061023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED TSP-50 UNIT IDENTIFIED FRETTING CORROSION ON ELECTRODES OF THE TWO INTERNAL POWER SUPPLIES WITHIN THE ENCLOSURE. THE CORROSION WAS DETERMINED TO BE A CONTRIBUTING FACTOR TO INTERMITTENT POWER LOSS OBSERVED DURING USE. THE AFFECTED AREAS WERE CLEANED WITH ELECTROLUBE CCS CLEANING STRIPS, AND A PROTECTIVE LUBRICANT (ELECTROLUBE CG60) WAS APPLIED TO REDUCE THE LIKELIHOOD OF RECURRENCE. FOLLOWING CORRECTIVE SERVICING, FUNCTIONAL TESTING WAS PERFORMED AND CONFIRMED THAT THE DEVICE OPERATED WITHIN ESTABLISHED PERFORMANCE SPECIFICATIONS DURING EXTENDED OPERATION. THE DEVICE WAS RETURNED TO THE HOSPITAL AND PLACED BACK INTO CLINICAL SERVICE.

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED TSP-50 UNIT IDENTIFIED FRETTING CORROSION ON ELECTRODES OF THE TWO INTERNAL POWER SUPPLIES WITHIN THE ENCLOSURE. THE CORROSION WAS DETERMINED TO BE A CONTRIBUTING FACTOR TO INTERMITTENT POWER LOSS OBSERVED DURING USE. THE AFFECTED AREAS WERE CLEANED WITH ELECTROLUBE CCS CLEANING STRIPS, AND A PROTECTIVE LUBRICANT (ELECTROLUBE CG60) WAS APPLIED TO REDUCE THE LIKELIHOOD OF RECURRENCE. FOLLOWING CORRECTIVE SERVICING, FUNCTIONAL TESTING WAS PERFORMED AND CONFIRMED THAT THE DEVICE OPERATED WITHIN ESTABLISHED PERFORMANCE SPECIFICATIONS DURING EXTENDED OPERATION. THE DEVICE WAS RETURNED TO THE HOSPITAL AND PLACED BACK INTO CLINICAL SERVICE. THIS IS A RESUBMISSION OF OUR INITIAL REPORT IN RESPONSE TO FDA'S MESSAGE OF 02/23/26. THE ORIGINAL MDR SHOULD HAVE CHECKED "INITIAL REPORT", NOT "5-DAY REPORT". IN ADDITION, WE CORRECTED THE DATE WE RECEIVED NOTICE OF THE PROBLEM, AS INDICATED IN BLOCK G3, TO THE CORRECT DATE OF (B)(6) 2024. PREVIOUSLY, THIS WAS ERRONEOUSLY REPORTED AS (B)(6) 2026. THIS WAS A TYPOGRAPHICAL ERROR.

    Description of Event or Problem · 0

    CLINICIANS AT GEISINGER MEDICAL CENTER USED THE LIFE RECOVERY SYSTEMS THERMOSUIT SYSTEM TO COOL A PATIENT FOLLOWING CARDIAC ARREST IN ACCORDANCE WITH THEIR STANDARD CLINICAL PRACTICE. THE TSP-50 PUMP WAS ACTIVATED WITH THE THERMOSUIT BODY ENCLOSURE (TBE) APPLIED TO THE PATIENT. THE TOP SHEET WAS ATTACHED TO THE TBE OVER THE FRONT OF THE PATIENT, LEAVING THE FACE EXPOSED. THE TSP-50 RESERVOIR WAS FILLED WITH APPROXIMATELY 40 LITERS OF ICE WATER. A 400-SERIES THERMISTOR TEMPERATURE PROBE FROM THE DISPOSABLES KIT WAS INSERTED INTO THE PATIENT'S ESOPHAGUS AND CONNECTED TO THE TSP-50 FOR CONTINUOUS TEMPERATURE MONITORING. SHORTLY AFTER ACTIVATION OF THE WATER PUMPS, THE TSP-50 EXPERIENCED INTERMITTENT POWER LOSS AND STOPPED CIRCULATING WATER THROUGH THE ENCLOSURE, REPRESENTING A DEVICE MALFUNCTION AND INTERRUPTION OF COOLING THERAPY. THE ATTENDING PHYSICIAN CONTACTED LRS TECHNICAL SUPPORT. DURING THE CALL, TECHNICAL SUPPORT DISCUSSED ALTERNATIVE TEMPERATURE MONITORING CONFIGURATION USING THE 400-SERIES PROBE AND A NEARBY COMPATIBLE TEMPERATURE MONITOR. CLINICAL STAFF REMOVED THE TOP SHEET FROM THE ENCLOSURE AND MANUALLY TRANSFERRED WATER FROM THE RESERVOIR ONTO THE FRONT OF THE PATIENT USING BASINS WHILE MONITORING TEMPERATURE EXTERNALLY. COOLING WAS CONTINUED UNTIL THE PATIENT REACHED THE INTENDED 34 °C TARGET. THE ENCLOSURE WAS THEN DRAINED AND REMOVED, AND THE PATIENT WAS TRANSITIONED TO A CONVENTIONAL TEMPERATURE MANAGEMENT BLANKET PER CLINICAL PRACTICE. THE MANUFACTURER WAS INFORMED THAT THE PATIENT RECOVERED AND WAS DISCHARGED WITH A GOOD OUTCOME. NO ADVERSE PATIENT EFFECTS WERE REPORTED TO THE MANUFACTURER. MANUFACTURER INITIATED INVESTIGATION AND PERFORMED CORRECTIVE AND PREVENTATIVE ACTIONS FOLLOWING RECEIPT OF THIS COMPLAINT.

    Description of Event or Problem · 0

    CLINICIANS AT (B)(6) MEDICAL CENTER USED THE LIFE RECOVERY SYSTEMS THERMOSUIT SYSTEM TO COOL A PATIENT FOLLOWING CARDIAC ARREST IN ACCORDANCE WITH THEIR STANDARD CLINICAL PRACTICE. THE TSP-50 PUMP WAS ACTIVATED WITH THE THERMOSUIT BODY ENCLOSURE (TBE) APPLIED TO THE PATIENT. THE TOP SHEET WAS ATTACHED TO THE TBE OVER THE FRONT OF THE PATIENT, LEAVING THE FACE EXPOSED. THE TSP-50 RESERVOIR WAS FILLED WITH APPROXIMATELY 40 LITERS OF ICE WATER. A 400-SERIES THERMISTOR TEMPERATURE PROBE FROM THE DISPOSABLES KIT WAS INSERTED INTO THE PATIENT'S ESOPHAGUS AND CONNECTED TO THE TSP-50 FOR CONTINUOUS TEMPERATURE MONITORING. SHORTLY AFTER ACTIVATION OF THE WATER PUMPS, THE TSP-50 EXPERIENCED INTERMITTENT POWER LOSS AND STOPPED CIRCULATING WATER THROUGH THE ENCLOSURE, REPRESENTING A DEVICE MALFUNCTION AND INTERRUPTION OF COOLING THERAPY. THE ATTENDING PHYSICIAN CONTACTED LRS TECHNICAL SUPPORT. DURING THE CALL, TECHNICAL SUPPORT DISCUSSED ALTERNATIVE TEMPERATURE MONITORING CONFIGURATION USING THE 400-SERIES PROBE AND A NEARBY COMPATIBLE TEMPERATURE MONITOR. CLINICAL STAFF REMOVED THE TOP SHEET FROM THE ENCLOSURE AND MANUALLY TRANSFERRED WATER FROM THE RESERVOIR ONTO THE FRONT OF THE PATIENT USING BASINS WHILE MONITORING TEMPERATURE EXTERNALLY. COOLING WAS CONTINUED UNTIL THE PATIENT REACHED THE INTENDED 34 °C TARGET. THE ENCLOSURE WAS THEN DRAINED AND REMOVED, AND THE PATIENT WAS TRANSITIONED TO A CONVENTIONAL TEMPERATURE MANAGEMENT BLANKET PER CLINICAL PRACTICE. THE MANUFACTURER WAS INFORMED THAT THE PATIENT RECOVERED AND WAS DISCHARGED WITH A GOOD OUTCOME. NO ADVERSE PATIENT EFFECTS WERE REPORTED TO THE MANUFACTURER. MANUFACTURER INITIATED INVESTIGATION AND PERFORMED CORRECTIVE AND PREVENTATIVE ACTIONS FOLLOWING RECEIPT OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215138 TSP-50 THERMOSUIT PUMP CONTROLLER CONSOLE THERMOSUIT PUMP NZE LIFE RECOVERY SYSTEMS TSP-50 00851936007003

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Unknown Required Intervention ALTRIX TEMPERATURE MANAGEMENT SYSTEM.| ALTRIX TEMPERATURE MANAGEMENT SYSTEM.