CARE-E-VAC 3Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08688250002436), received between Aug 8, 2018 and Nov 24, 2018 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K062610); they may or may not involve this specific model.

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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2018Thermal Decomposition of Device; Nonstandard Device

  DEVICE WAS SUBJECT TO FCA 1419185-7/24/18-001-C, AND USER FACILITY NOTICED BURNT BATTERY WIRES. UPON RETURN TO MANUFACTURER ON (B)(6) 2018 IN WAS CONFIRMED THAT WIRES WERE IN FACT BURNED. THE ROOT CAUSE WAS FOUND TO BE THE SAME REASON FOR FIELD CORRECTIVE ACTION INITIATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100344 ↗
• MalfunctionNov 24, 2018Thermal Decomposition of Device; Nonstandard Device

  DEVICE WAS SUBJECT TO FCA 1419185-7/24/18-001-C, AND USER FACILITY NOTICED BURNT BATTERY WIRES. UPON DEVICE RETURN TO MANUFACTURER ON (B)(6) 2018 IT WAS NOTED THAT WIRES WERE IN FACT BURNED. THE ROOT CAUSE WAS FOUND TO BE THE SAME AS REASON FOR FIELD CORRECTIVE ACTION INITIATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100343 ↗
• MalfunctionNov 19, 2018Thermal Decomposition of Device; Nonstandard Device; Smoking

  DEVICE WAS SUBJECT TO (B)(4), AND USER FACILITY NOTICED SMOKING, AND UPON DEVICE RETURN TO MANUFACTURER IT WAS NOTED THAT WIRES WERE IN FACT BURNED. THE ROOT CAUSE WAS FOUND TO BE THE SAME AS REASON FOR FIELD CORRECTIVE ACTION INITIATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8086683 ↗
• MalfunctionAug 13, 2018Material Discolored; Nonstandard Device; Device Emits Odor; Electrical Shorting

  COMPLAINT WAS RECEIVED ON (B)(6) 2018 STATING "AFTER FINAL VISUAL INSPECTION OF THE CARE E VACS A TOTAL OF THREE UNITS ALL HAVE DISCOLORATION TO THE CASING, AND SMELL AS IF THE UNIT HAS BEEN SHORTED OUT. UPON RETURN TO OHIO MEDICAL ON JULY 19, 2018 AND REPAIR CENTER EVALUATION ON JULY 24, 2018 IT WAS NOTED "DUE TO EXTENT OF DAMAGE, UNIT IS BEYOND ECONOMICAL REPAIR". FURTHER EVALUATION WAS PERFORMED BY ENGINEERING WHICH DETERMINED THAT A SHORT OCCURRED WHEN BATTERY TERMINALS SUSPECTEDLY CAME INTO CONTACT WITH PUMP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7779345 ↗
• MalfunctionAug 13, 2018Thermal Decomposition of Device; Nonstandard Device; Device Emits Odor; Electrical Shorting

  COMPLAINT WAS RECEIVED ON (B)(6) 2018 STATING "AFTER FINAL VISUAL INSPECTION OF THE CARE E VACS A TOTAL OF THREE UNITS ALL HAVE DISCOLORATION TO THE CASING, AND SMELL AS IF THE UNIT HAS BEEN SHORTED OUT. UPON RETURN TO (B)(6) ON (B)(6) 2018 AND REPAIR CENTER EVALUATION ON JULY 24, 2018 IT WAS NOTED "DUE TO EXTENT OF DAMAGE, UNIT IS BEYOND ECONOMICAL REPAIR". FURTHER EVALUATION WAS PERFORMED BY ENGINEERING WHICH DETERMINED THAT A SHORT OCCURED WHEN BATTERY TERMINALS SUSPECTEDLY CAME INTO CONTACT WITH PUMP.

  Patient problems: No Information

  MAUDE report 7778884 ↗
• MalfunctionAug 9, 2018Melted

  ON (B)(6) 2018 A COMPLAINT WAS RECEIVED FOR THE CARE-E-VAC 3 DEVICE IN WHICH THE CUSTOMER STATED "ONE OF THE UNITS LOOKS DAMAGED/ USED". THE DEVICE WAS RETURNED ON 06/21/2018 AND A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER. ON (B)(6) 2018 THERE WAS AN OCCURRENCE IN HOUSE DURING ASSEMBLY OF THE CARE-E-VAC 3 DEVICE IN WHICH SAME TIME OF EFFECT OCCURRED (MELTED WIRES LEADING FROM BATTERY TO THE PC BOARD). SHIP HOLD WAS INITIATED IMMEDIATELY AND INVESTIGATION BEGAN LOOKING FURTHER INTO THE CAUSE OF THE MELTED WIRES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7771116 ↗
• MalfunctionAug 9, 2018Melted; Smoking

  ON (B)(6) 2018 A COMPLAINT WAS RECEIVED FOR THE CARE-E-VAC 3 DEVICE IN WHICH THE CUSTOMER STATED "UNIT WAS SMOKING AND HAD TO CLEAR OUT THE UNIT FROM ROOM LOCATED, HE FOUND BURNT WIRES AND BURNT MARKS INSIDE THE UNIT". CUSTOMER WAS CONTACTED ON 4/11/2018 TO OBTAIN ADDITIONAL INFORMATION. IT WAS STATED BY MR. (B)(6) THAT HE RECEIVED A CALL ABOUT SMOKE DETECTED ON A PATIENT FLOOR. THE AREA WAS EVACUATED BECAUSE IT COULD NOT BE DETERMINED WHERE THE SMOKE WAS COMING FROM. MR. (B)(6) REMOVED 3 DIFFERENT PORTABLE DEVICES AND BROUGHT THEM TO THE BIO-MED AREA FOR FURTHER INVESTIGATION, AND AREA WAS THEN ALLOWED TO BE USED. WHILE IN THE BIOMED AREA THE CARE-E-VAC 3 DEVICE WAS OPENED UP AND IT WAS THEN NOTED THAT INSULATION ON WIRES HAD MELTED. IT WAS STATED BY MR. (B)(6) THAT THE DEVICE WAS BEING STORED (NOT IN USE) ON THE DEPARTMENT CODE CART WHEN SMOKE SMELL WAS NOTED, AND THAT THE LAST TIME THE DEVICE WAS VERIFIED TO BE IN WORKING ORDER WAS SOMETIME DURING FEBRUARY 2018. UPON RETURN TO THE MANUFACTURER ON 04/23/2018 THE FOLLOWING WAS NOTED BY THE REPAIR TECHNICIAN "DUE TO EXTENT OF DAMAGE, UNIT IS BEYOND ECONOMICAL REPAIR (BER)." A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER. IT WAS DETE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7771090 ↗
• MalfunctionAug 8, 2018Thermal Decomposition of Device; Electrical /Electronic Property Problem; Melted; Nonstandard Device; Unsealed Device Packaging; Device Damaged Prior to Use

  ON 11/15/2017 A COMPLAINT WAS RECEIVED FOR THE CARE-E-VAC 3 DEVICE IN WHICH THE CUSTOMER STATED "OUT OF BOX FAILURE". UPON RETURN TO THE MANUFACTURER ON 12/7/2017 THE FOLLOWING WAS NOTED BY THE REPAIR TECHNICIAN " NOTE: THIS IS NOT AN OUT OF BOX FAILURE. EVIDENCE OF EXTENSIVE USE AND SEAL BROKEN INDICATING UNIT HAS BEEN OPENED. INSPECTION IN REPAIR CENTER SHOWS THIS UNIT HAD LIQUID DAMAGE CAUSING CATASTROPHIC ELECTRICAL FAILURE." PICTURES WERE PROVIDED THAT SHOW MELTED WIRES FROM THE DEVICE BATTERY TO THE PC BOARD. DEVICE WAS RETAINED BY ENGINEERING. ON (B)(6) 2018 THERE WAS AN OCCURENCE IN HOUSE DURING ASSEMBLY OF THE CARE-E-VAC 3 DEVICE IN WHICH SAME TIME OF EFFECT OCCURED (MELTED WIRES LEADING FROM BATTERY TO THE PC BOARD). SHIP HOLD WAS INITIATED IMMEDIATELY AND INVESTIGATION BEGAN LOOKING FURTHER INTO THE CAUSE OF THE BURNING/ MELTED WIRES. THIS DEVICE WAS RE-EVALUATED BY ENGINEERING WITH COMPARISON TO FAILURE WHICH OCCURED IN HOUSE. SAME EFFECTS OF FAILURE WERE OBSERVED.

  Patient problems: No Patient Involvement

  MAUDE report 7765710 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062610. One submission often covers many models, so check the product and lot details in each record.

• Z-2995-2018 · Aug 14, 2018 · Terminated
  Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspira
• Z-0833-2011 · Nov 8, 2010 · Terminated
  Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 758000 The device is a portable aspirator to h