MAUDE Adverse Event Report: LIFE RECOVERY SYSTEMS TSP-50 THERMOSUIT PUMP CONTROLLER CONSOLE

Model Number	TSP-50
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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 12/04/24.Previously, this was erroneously reported as 12/04/26.This was a typographical error.

• Brand Name: TSP-50 THERMOSUIT PUMP CONTROLLER CONSOLE
• Common Device Name: THERMOSUIT PUMP
• Manufacturer (Section D): LIFE RECOVERY SYSTEMS; 170 kinnelon road; suite 5; kinnelon NJ 07405
• Manufacturer (Section G): LIFE RECOVERY SYSTEMS; 170 kinnelon road; suite 5; kinnelon NJ 07405
• Manufacturer Contact: robert schock ; 170 kinnelon road; suite 5; kinnelon, NJ 07405 ; 9732832800
• MDR Report Key: 24345778
• Report Number: 3006059109-2026-00001
• Device Sequence Number: 9912154
• Product Code: NZE
• UDI-Device Identifier: 00851936007003
• UDI-Public: 00851936007003
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K061023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Repair,Notification,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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
• Operator of Device: Health Professional
• Device Model Number: TSP-50
• Device Catalogue Number: 59002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 12/04/2026
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRIX TEMPERATURE MANAGEMENT SYSTEM.; ALTRIX TEMPERATURE MANAGEMENT SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White