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T/Pump TP700Recalls & reported problems

Stryker Corporation · Class 2

Adverse event reports
15
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327169249), received between Nov 20, 2018 and May 25, 2022 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem6
  • Electrical /Electronic Property Problem2
  • Overheating of Device2
  • Patient-Device Incompatibility2
  • Excessive Heating1
  • Incorrect, Inadequate or Imprecise Result or Readings1
  • Insufficient Device Problem Information1
  • Patient Device Interaction Problem1

Patient problems

  • Burn, Thermal4
  • Partial thickness (Second Degree) Burn3
  • No Patient Involvement2
  • Superficial (First Degree) Burn2
  • Burn(s)1
  • Hyperemia1
  • Injury1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    (B)(6) EMAILED C2DX ON 5/4/2022 INDICATING THAT A BURN INCIDENT HAD OCCURRED AT A LOCATION THAT AGILITI HEALTH SERVICES, REFERRED TO AS (B)(6) HOSPITAL. THE PATIENT WAS UNDERGOING A FOUR-HOUR SURGERY AROUND NOON ON (B)(6), AND THE T/PUMP WAS BEING USED.

    Patient problems: Partial thickness (Second Degree) Burn

    MAUDE report 14500587 ↗
  • MalfunctionOct 28, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THERE WAS ACCESSIBLE AC SHOCK. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10748277 ↗
  • MalfunctionJul 24, 2020Excessive Heating; Excessive Heating

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THERE WAS EXCESSIVE HEATING. THE PATIENT SUSTAINED A BURN/SKIN IRRITATION.

    Patient problems: Burn(s); Skin Irritation

    MAUDE report 10320404 ↗
  • MalfunctionOct 29, 2019Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Patient Device Interaction Problem

    IT WAS ALLEGED THAT WHILE THE PATIENT WAS LYING ON THE PAD, THEY ALLEGEDLY RECEIVED A 1ST DEGREE BURN.

    Patient problems: Hyperemia; Superficial (First Degree) Burn

    MAUDE report 9249438 ↗
  • MalfunctionAug 6, 2019Patient-Device Incompatibility

    IT WAS REPORTED THAT THE PATIENT HAD BLISTERS REPORTEDLY FROM THE PADS. FURTHER INFORMATION WAS NOT PROVIDED.

    Patient problems: Injury

    MAUDE report 8866572 ↗
  • InjuryAug 6, 2019Patient-Device Incompatibility

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF LOWER BACK PAIN. THE CNA'S ALLEGEDLY OBSERVED 1ST DEGREE AND 2ND DEGREE BURNS ON PATIENT FROM PADS. IT WAS REPORTED THAT THE PATIENT WAS OVERWEIGHT, AND UNABLE TO TURN IN THE BED, NOTHING WAS PLACED IN BETWEEN THE PATIENT AND THE PAD.

    Patient problems: Pain; Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

    MAUDE report 8866567 ↗
  • MalfunctionJul 29, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE UNIT FAILED THE ELECTRICAL SAFETY TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 8835617 ↗
  • InjuryJul 23, 2019Temperature Problem; Adverse Event Without Identified Device or Use Problem; Temperature Problem

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY RECEIVED A BURN TO THEIR LOWER BACK. FURTHER INFORMATION WAS NOT PROVIDED.

    Patient problems: Burn, Thermal; Pressure Sore/Ulcer

    MAUDE report 8818417 ↗
  • MalfunctionJul 22, 2019Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY RECEIVED BURN MARKS FROM THE THERAPY PAD. FURTHER INFORMATION HAS NOT BEEN PROVIDED.

    Patient problems: Burn, Thermal

    MAUDE report 8812847 ↗
  • InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem

    A PATIENT HAD SUPERFICIAL BURNS TO HER BACK AND PARTIAL THICKNESS BURNS TO (2) AREAS WITH THE WORST OVER THE LEFT SCAPULA. THE PATIENT HAD WOUND CARE PROVIDED FOLLOWING THE EVENT CONSISTING OF XEROFOAM TO BLISTERS WITH AN OPTIFOAM GENTLE DRESSING.

    Patient problems: Partial thickness (Second Degree) Burn; Swelling

    MAUDE report 8613538 ↗
  • MalfunctionApr 19, 2019Incorrect, Inadequate or Imprecise Result or Readings

    IT WAS REPORTED THAT THE DEVICE IS FAILING ELECTRICAL SAFETY TEST. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8531008 ↗
  • MalfunctionJan 31, 2019Overheating of Device

    IT WAS REPORTED THAT THE PAD GOT HOT AND THE BACK OF THE NECK WAS RED. MEDICAL INTERVENTION WAS NOT REPORTED.

    Patient problems: Skin Discoloration

    MAUDE report 8294869 ↗
  • MalfunctionJan 25, 2019Overheating of Device; Overheating of Device

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE UNIT OVERHEATED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 8279095 ↗
  • MalfunctionNov 20, 2018Insufficient Device Problem Information

    IT WAS ALLEGED THAT WHILE POSSIBLY USING ATP700 TO WARM A PATIENT, THE PATIENT BECAME VISIBLY BURNED. THE BURN ALLEGEDLY RESEMBLED THE "HONEYCOMB" PATTERN OF THE BLANKET/PADS.

    Patient problems: Burn, Thermal

    MAUDE report 8092188 ↗
  • MalfunctionNov 20, 2018Adverse Event Without Identified Device or Use Problem

    IT WAS ALLEGED THAT WHILE POSSIBLY USING ATP700 TO WARM A PATIENT, THE PATIENT BECAME VISIBLY BURNED. THE BURN ALLEGEDLY RESEMBLED THE "HONEYCOMB" PATTERN OF THE BLANKET/PADS.

    Patient problems: Burn, Thermal

    MAUDE report 8092186 ↗

Other Pack, hot or cold, water circulating devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.