Altitude 8888571370 (UDI 10884521060975)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521060975), received between May 12, 2017 and Jun 4, 2024 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE CLOSED CHEST TUBE DRAINAGE SYSTEM (AQUA-SEAL) SHOWED DISCONNECTION WITHOUT TRACTION. THE CUSTOMER STATED THAT THE COLLECTION BOTTLE EXTENSION (AQUA-SEAL) THAT CONNECTS TO THE CHEST DRAIN IS MADE OF PVC MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19464208 ↗
• MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE CLOSED CHEST TUBE DRAINAGE SYSTEM (AQUA-SEAL) SHOWED DISCONNECTION WITHOUT TRACTION. THE CUSTOMER STATED THAT THE COLLECTION BOTTLE EXTENSION (AQUA-SEAL) THAT CONNECTS TO THE CHEST DRAIN IS MADE OF PVC MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19464207 ↗
• MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE CLOSED CHEST TUBE DRAINAGE SYSTEM (AQUA-SEAL) SHOWED DISCONNECTION WITHOUT TRACTION. THE CUSTOMER STATED THAT THE COLLECTION BOTTLE EXTENSION (AQUA-SEAL) THAT CONNECTS TO THE CHEST DRAIN IS MADE OF PVC MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19464191 ↗
• MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE CLOSED CHEST TUBE DRAINAGE SYSTEM (AQUA-SEAL) SHOWED DISCONNECTION WITHOUT TRACTION. THE CUSTOMER STATED THAT THE COLLECTION BOTTLE EXTENSION (AQUA-SEAL) THAT CONNECTS TO THE CHEST DRAIN IS MADE OF PVC MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463961 ↗
• MalfunctionMar 26, 2024Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THE PATIENT ARRIVED TO THE CICU FOLLOWING CARDIAC SURGERY. WHEN CARDIAC DRAINS WERE ATTACHED TO THE APPROPRIATE SUCTION, IT DID NOT WORK EFFECTIVELY. THE GREEN SUCTION / PATIENT VACUUM INDICATOR DID NOT APPEAR AS IT SHOULD ON THE ALTITUDE DRAIN. WALL SUCTION WAS CHECKED AND IT WAS WORKING ADEQUATELY THEREFORE THE ISSUE WAS WITH THE ALTITUDE CDU DRAINAGE BOTTLE. THERE HAS BEEN 4 SIMILAR INCIDENTS (EXACT NUMBER UNKNOWN) IN THE RECENT PAST REGARDING THE SAME ISSUE. PER ADDITIONAL INFORMATION RECEIVED, THE BEDSIDE NURSE ESCALATED THE ISSUE WITH NOT BEING ABLE TO SEE THERE WAS SUCTION BEING APPLIED. AFTER INVESTIGATING AND CHECKING THE WALL SUCTION WAS WORKING, THE DECISION WAS MADE TO CHANGE THE DRAINAGE BOTTLE TO ENSURE PATIENT SAFETY. THIS IS AN UNNECESSARY INTERVENTION (AS THE DRAINS SHOULD BE WORKING APPROPRIATELY WITH ANY ADDED SUCTION BEING INDICATED). THERE WAS NO HARM TO THE PATIENT, HOWEVER IT IS OF GREAT IMPORTANCE THAT THE DRAINS BE ON SUCTION DUE TO THE NATURE OF THE SURGERY, THE CHANGING OF THE DRAINAGE BOTTLE INCREASES THE RISK OF INFECTION TO THE PATIENT DESPITE THE PROCEDURE BEING DONE USING ANTT/ IN A STERILE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18981914 ↗
• InjurySep 6, 2022Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THE PATIENT WAS WITH A CHEST TUBE SINCE (B)(6) 2022 DUE TO THE PRESENCE OF HEMOTHORAX. THEY WERE ADMITTED TO THE INTERMEDIATE CARE UNIT ON (B)(6) 2022 AND ON (B)(6) 2022 DRAINAGE WAS OBSERVED IN THE WATER SEAL CHAMBER AND REST OF THE DRAINAGE IN ALL THE COLLECTING CHAMBERS WITHOUT THE FIRST ONE BEING FULL. IN ROUNDS, THE DOCTOR REPORTS THE FINDING AND THAT THE MEDICAL DEVICE HAS NOT FALLEN, SO A CHEST TOMOGRAPHY IS PERFORMED AND EVIDENCE OF COAGULATED HEMOTHORAX REQUIRING SURGICAL INTERVENTION THE NEXT DAY TO PERFORM DRAINAGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15365364 ↗
• MalfunctionAug 25, 2020Decrease in Suction; Decrease in Suction

  THE CUSTOMER REPORTED THEY HAVE NOTICED THAT THE ALTITUDE CHEST DRAINAGE SYSTEM DOES NOT MAINTAIN SUCTION AND THE TEAMS REPORT AN AIR LEAK SOUND. THE PATIENT HAD TO RETURN TO THE RECOVERY ROOM TO CHANGE THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10448194 ↗
• MalfunctionJun 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTS A DISCONNECTION OCCURRED WHERE THE TROCAR CATHETER CONNECTS TO THE TUBING/CONNECTOR PIECE OF THE CHEST DRAINAGE UNIT. THE CONNECTION IS INITIALLY TIGHT, BUT BECAME LOOSE AND DISCONNECTED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8684290 ↗
• MalfunctionJun 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTS A DISCONNECTION OCCURRED WHERE THE TROCAR CATHETER CONNECTS TO THE TUBING/CONNECTOR PIECE OF THE CHEST DRAINAGE UNIT. THE CONNECTION IS INITIALLY TIGHT, BUT BECAME LOOSE AND DISCONNECTED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8682924 ↗
• MalfunctionJun 27, 2018Leak/Splash; Leak/Splash

  CUSTOMER REPORTS: ON ARRIVAL TO THE DCCM POST-OP CARDIAC BYPASS SURGERY, THE ALTITUDE CHEST DRAIN WAS PLACED ON -20CMH20. THE DRAIN COMMENCED BUBBLING CONSTANTLY THROUGHOUT INSPIRATION AND EXPIRATION ON A VENTILATED PATIENT. SUCTION WAS REMOVED AND THE DRAIN STOPPED BUBBLING. WHEN THE SUCTION WAS REAPPLIED, THE DRAIN RESUMED BUBBLING. THE DRAINAGE TUBING WAS THEN OCCLUDED, AND THE BUBBLING CONTINUED. WHEN THE SUCTION WAS REDUCED TO -10CMH20, THE BUBBLING CONTINUED. THE CLINICIAN CHANGED THE ALTITUDE DRAIN TO ANOTHER ALTITUDE DRAIN IN STOCK, RESUMED -20CMH20 AND THE BUBBLING CEASED. SWINGING (OSCILLATION) AND DRAINAGE WERE UNAFFECTED. PER FOLLOW UP INFORMATION RECEIVED, THE CUSTOMER FURTHER STATED THAT THERE WAS A LEAKAGE IN THE WATER SEAL CHAMBER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7643104 ↗
• MalfunctionDec 22, 2017Air Leak; Air Leak

  THE CUSTOMER STATES AIR IN DRAINAGE.

  Patient problems: No Information

  MAUDE report 7143721 ↗
• MalfunctionOct 17, 2017Kinked; Kinked

  ACCORDING TO THE REPORTER, ON (B)(6) 2017, DURING USE, THE DEVICE'S DRAINAGE HAD LEAKAGE AND NO PRESSURE WHEN TUBING WAS KINKED. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6955430 ↗
• MalfunctionAug 4, 2017Suction Problem; Suction Problem

  THE CUSTOMER REPORTS LEAK AT THE LEVEL OF "SATCHEL". THERE ARE SOME ABNORMAL BUBBLES. WHILE THE PATIENT HAD A PULMONARY LEAK PROBLEM. THE "SATCHEL" DOESN'T WORK, THEREFORE NO SUCTION FOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6768361 ↗
• MalfunctionMay 12, 2017Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED SIGNIFICANT LEAKAGE OF PLEURAL FLUID AT THE BLUE FITTING IN THE WATER SEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6562958 ↗