ENDOSCOPIC CO2 REGULATION UNIT OLYMPUS UCR (UDI 04953170239748)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04953170239748), received between Aug 2, 2019 and Feb 11, 2026 — classified as 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Infusion or Flow Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313072 ↗
• InjuryNov 22, 2024Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING A SCREENING COLONOSCOPY, WHEN ANGULATING THE SCOPE, IT WOULD LOCK. THE PHYSICIAN WAS THUS UNABLE TO DISENGAGE DURING REMOVAL OF A POLYP, CAUSING THE COLON TO TEAR/PERFORATE. IT IS UNCLEAR IF THIS PATIENT UNDERWENT ANY TREATMENT. THE PHYSICIAN STATED THAT THE COLON WAS NOT INSUFFLATING DURING THE PROCEDURE, AND IT WAS UNCLEAR IF THE INSUFFLATOR MALFUNCTIONED OR IF THERE WAS A PROBLEM WITH THE SCOPE, OR IF IT WAS SOMETHING ELSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PENDING INFORMATION. THE CUSTOMER INDICATED 6 CASES OF PERFORATIONS OCCURRED. THUS, ADDITIONAL 4 CASES ARE REPORTED FOR PERFORATION. 2 PATIENTS HAD MICRO-PERFORATIONS IN THE COLON WERE TREATED. 4 PATIENTS HAD SURGERIES: REPAIR IN 1 PATIENT AND HEMICOLECTOMY IN 3 PATIENTS.

  Patient problems: Bowel Perforation

  MAUDE report 20765968 ↗
• InjuryNov 22, 2024Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING A SCREENING COLONOSCOPY, WHEN ANGULATING THE SCOPE, IT WOULD LOCK. THE PHYSICIAN WAS THUS UNABLE TO DISENGAGE DURING REMOVAL OF A POLYP, CAUSING THE COLON TO TEAR/PERFORATE. IT IS UNCLEAR IF THIS PATIENT UNDERWENT ANY TREATMENT. THE PHYSICIAN STATED THAT THE COLON WAS NOT INSUFFLATING DURING THE PROCEDURE, AND IT WAS UNCLEAR IF THE INSUFFLATOR MALFUNCTIONED OR IF THERE WAS A PROBLEM WITH THE SCOPE, OR IF IT WAS SOMETHING ELSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PENDING INFORMATION. THE CUSTOMER INDICATED 6 CASES OF PERFORATIONS OCCURRED. THUS, ADDITIONAL 4 CASES ARE REPORTED FOR PERFORATION. 2 PATIENTS HAD MICRO-PERFORATIONS IN THE COLON WERE TREATED. 4 PATIENTS HAD SURGERIES: REPAIR IN 1 PATIENT AND HEMICOLECTOMY IN 3 PATIENTS.

  Patient problems: Bowel Perforation

  MAUDE report 20762106 ↗
• MalfunctionSep 11, 2024Leak/Splash; Pressure Problem; Leak/Splash; Pressure Problem

  IT WAS REPORTED THAT THE ENDOSCOPIC CO2 REGULATOR UNIT PRODUCED TOO MUCH PRESSURE AND THE SCOPES SOMETIMES LEAKED. THE ISSUES OCCURRED DURING UNSPECIFIED PROCEDURES. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20187122 ↗
• MalfunctionJul 5, 2022Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED TO OLYMPUS, DURING A PROCEDURE, THE ENDOSCOPIC CO2 REGULATION UNIT MADE A LOT OF NOISE AND THE STOMACH OF THE PATIENT HAD SWOLLEN TOO MUCH. THE ISSUE OCCURRED WITH TWO (2) PATIENTS. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED, AND NO MORE VISITS HAD TO BE MADE. THE FACILITY CONTINUES TO WORK WITH THE DEVICE AS USUAL. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIER (B)(6) (ENDOSCOPIC CO2 REGULATION UNIT, UCR).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914228 ↗
• MalfunctionJul 5, 2022Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED TO OLYMPUS, DURING A PROCEDURE, THE ENDOSCOPIC CO2 REGULATION UNIT MADE A LOT OF NOISE AND THE STOMACH OF THE PATIENT HAD SWOLLEN TOO MUCH. THE ISSUE OCCURRED WITH TWO (2) PATIENTS. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED, AND NO MORE VISITS HAD TO BE MADE. THE FACILITY CONTINUES TO WORK WITH THE DEVICE AS USUAL. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIER (B)(6) (ENDOSCOPIC CO2 REGULATION UNIT, UCR).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914193 ↗
• MalfunctionMay 7, 2021Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT IS REPORTED DURING A COLONOSCOPY USING AN ENDOSCOPIC CO2 REGULATION UNIT WITH A H190 SCOPE, THE PATIENT EXPERIENCED BAROTRAUMA. THE PATIENT EXPERIENCED NO ILL EFFECTS DURING OR AFTER THE PROCEDURE RELATED TO THE BAROTRAUMA AND REQUIRED NO MEDICAL OR SURGICAL INTERVENTION AS A RESULT. THE CUSTOMER REPORTED THEY BEEN MONITORING THIS EQUIPMENT AND DISCUSSING WITH THE PHYSICIANS AND THERE HAVE NOT BEEN ANY NEW CONCERNS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11790098 ↗
• MalfunctionOct 15, 2020Infusion or Flow Problem; Infusion or Flow Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING PREPARATION FOR USE OF THE SUBJECT DEVICE, THE FAILURE OF INSUFFLATION CO2 OCCURRED INTERMITTENTLY. OLYMPUS (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON COULD NOT DUPLICATED AND THE FOREIGN MATTER HAD ENTERED THE GAS TUBE DUE TO THE DAMAGE OF THE INTERNAL COMPONENT. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10683063 ↗
• InjuryOct 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "COMPARISON BETWEEN SUBMUCOSAL TUNNELING ENDOSCOPIC RESECTION AND VIDEO-ASSISTED THORACOSCOPIC ENUCLEATION FOR ESOPHAGEAL SUBMUCOSAL TUMORS ORIGINATING FROM THE MUSCULARIS PROPRIA LAYER: A RANDOMIZED CONTROLLED TRIAL". THE LITERATURE REPORTED THE RESULTS OF A STUDY BASED ON SUBMUCOSAL TUNNELING ENDOSCOPIC RESECTION (STER) OR VIDEO-ASSISTED THORACOSCOPIC ENUCLEATION (VATE) OF 66 PATIENTS WITH SMALL ESOPHAGEAL SUBMUCOSAL TUMORS BETWEEN JULY, 2014 TO DECEMBER, 2015. DURING THE STUDY PERIOD, STER WERE PERFORMED WITH THE USE OF THE SUBJECT DEVICE (OLYMPUS INSUFFLATOR: UCR), AND SUBCUTANEOUS OR MEDIASTINAL EMPHYSEM OCCURRED IN 3 PATIENT. THERE IS NO DESCRIPTION ABOUT THE RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND ADVERSE EVENTS, AND NO DESCRIPTION ABOUT THE SEVERITY OR OUTCOME OF THE ADVERSE EVENTS.

  Patient problems: Injury

  MAUDE report 10624658 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "PERORAL ENDOSCOPIC MYOTOMY IN CHILDREN WITH ACHALASIA: A RELATIVELY LONG-TERM SINGLE-CENTER STUDY". THE LITERATURE REPORTED THE RESULT OF 21 CASES OF THE PERORAL ENDOSCOPIC MYOTOMY (POEM) USING OLYMPUS MODEL UCR BETWEEN OCTOBER, 2014 AND OCTOBER, 2016. IN THE 21 CASES OF THE POEM, THE SIX PATIENTS DEVELOPED COMPLICATIONS. THE FIRST PATIENT WHO WAS (B)(6) MONTH-OLD GIRL, DEVELOPED SUBCUTANEOUS EMPHYSEMA AND PNEUMOPERITONEUM, WHICH MANIFESTED AS SUBCUTANEOUS EMPHYSEMA IN THE HEAD, NECK, ANTERIOR CHEST, AND EMPHYSEMA IN THE ABDOMEN DURING THE OPERATION. THIS PATIENT RECEIVED ABDOMINOCENTESIS AND HER EMPHYSEMA RECOVERED. THE SECOND PATIENT DEVELOPED SUBCUTANEOUS AND MEDIASTINAL EMPHYSEMA DURING THE OPERATION, WHICH SPONTANEOUSLY RESOLVED AS REVEALED BY CHEST X-RAY. ADDITIONALLY FOUR PATIENTS DEVELOPED SUBCUTANEOUS OR MEDIASTINAL EMPHYSEMA AS POSTOPERATIVE COMPLICATIONS, WHICH WERE MANIFESTED BY POSTOPERATIVE X-RAY OR CT SCANS. ONE OF FOUR PATIENTS DEVELOPED FEVER AND SYMPTOMS OF PNEUMONIA, HOWEVER, RECOVERED AFTER ANTIBIOTICS ADMINISTRATION. FURTHER DETAILED INFORMATION COULD NOT BE OBTAINED FROM THE USER FACILITY AT PRE

  Patient problems: Injury

  MAUDE report 9760758 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "PERORAL ENDOSCOPIC MYOTOMY IN CHILDREN WITH ACHALASIA: A RELATIVELY LONG-TERM SINGLE-CENTER STUDY". THE LITERATURE REPORTED THE RESULT OF 21 CASES OF THE PERORAL ENDOSCOPIC MYOTOMY (POEM) USING OLYMPUS MODEL UCR BETWEEN OCTOBER, 2014 AND OCTOBER, 2016. IN THE 21 CASES OF THE POEM, THE SIX PATIENTS DEVELOPED COMPLICATIONS. THE FIRST PATIENT WHO WAS (B)(6) OLD GIRL, DEVELOPED SUBCUTANEOUS EMPHYSEMA AND PNEUMOPERITONEUM, WHICH MANIFESTED AS SUBCUTANEOUS EMPHYSEMA IN THE HEAD, NECK, ANTERIOR CHEST, AND EMPHYSEMA IN THE ABDOMEN DURING THE OPERATION. THIS PATIENT RECEIVED ABDOMINOCENTESIS AND HER EMPHYSEMA RECOVERED. THE SECOND PATIENT DEVELOPED SUBCUTANEOUS AND MEDIASTINAL EMPHYSEMA DURING THE OPERATION, WHICH SPONTANEOUSLY RESOLVED AS REVEALED BY CHEST X-RAY. ADDITIONALLY FOUR PATIENTS DEVELOPED SUBCUTANEOUS OR MEDIASTINAL EMPHYSEMA AS POSTOPERATIVE COMPLICATIONS, WHICH WERE MANIFESTED BY POSTOPERATIVE X-RAY OR CT SCANS. ONE OF FOUR PATIENTS DEVELOPED FEVER AND SYMPTOMS OF PNEUMONIA, HOWEVER, RECOVERED AFTER ANTIBIOTICS ADMINISTRATION. FURTHER DETAILED INFORMATION COULD NOT BE OBTAINED FROM THE USER FACILITY AT PRESENT.

  Patient problems: Injury

  MAUDE report 9760722 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "PERORAL ENDOSCOPIC MYOTOMY IN CHILDREN WITH ACHALASIA: A RELATIVELY LONG-TERM SINGLE-CENTER STUDY". THE LITERATURE REPORTED THE RESULT OF 21 CASES OF THE PERORAL ENDOSCOPIC MYOTOMY (POEM) USING OLYMPUS MODEL UCR BETWEEN (B)(6) 2014 AND (B)(6) 2016. IN THE 21 CASES OF THE POEM, THE SIX PATIENTS DEVELOPED COMPLICATIONS. THE FIRST PATIENT WHO WAS (B)(6)-OLD GIRL, DEVELOPED SUBCUTANEOUS EMPHYSEMA AND PNEUMOPERITONEUM, WHICH MANIFESTED AS SUBCUTANEOUS EMPHYSEMA IN THE HEAD, NECK, ANTERIOR CHEST, AND EMPHYSEMA IN THE ABDOMEN DURING THE OPERATION. THIS PATIENT RECEIVED ABDOMINOCENTESIS AND HER EMPHYSEMA RECOVERED. THE SECOND PATIENT DEVELOPED SUBCUTANEOUS AND MEDIASTINAL EMPHYSEMA DURING THE OPERATION, WHICH SPONTANEOUSLY RESOLVED AS REVEALED BY CHEST X-RAY. ADDITIONALLY FOUR PATIENTS DEVELOPED SUBCUTANEOUS OR MEDIASTINAL EMPHYSEMA AS POSTOPERATIVE COMPLICATIONS, WHICH WERE MANIFESTED BY POSTOPERATIVE X-RAY OR CT SCANS. ONE OF FOUR PATIENTS DEVELOPED FEVER AND SYMPTOMS OF PNEUMONIA, HOWEVER, RECOVERED AFTER ANTIBIOTICS ADMINISTRATION. FURTHER DETAILED INFORMATION COULD NOT BE OBTAINED FROM THE USER FACILITY AT PRESENT. ACCO

  Patient problems: Injury

  MAUDE report 9760710 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "PERORAL ENDOSCOPIC MYOTOMY IN CHILDREN WITH ACHALASIA: A RELATIVELY LONG-TERM SINGLE-CENTER STUDY". THE LITERATURE REPORTED THE RESULT OF 21 CASES OF THE PERORAL ENDOSCOPIC MYOTOMY (POEM) USING OLYMPUS MODEL UCR BETWEEN OCTOBER, 2014 AND OCTOBER, 2016. IN THE 21 CASES OF THE POEM, THE SIX PATIENTS DEVELOPED COMPLICATIONS. THE FIRST PATIENT WHO WAS (B)(6) MONTH-OLD GIRL, DEVELOPED SUBCUTANEOUS EMPHYSEMA AND PNEUMOPERITONEUM, WHICH MANIFESTED AS SUBCUTANEOUS EMPHYSEMA IN THE HEAD, NECK, ANTERIOR CHEST, AND EMPHYSEMA IN THE ABDOMEN DURING THE OPERATION. THIS PATIENT RECEIVED ABDOMINOCENTESIS AND HER EMPHYSEMA RECOVERED. THE SECOND PATIENT DEVELOPED SUBCUTANEOUS AND MEDIASTINAL EMPHYSEMA DURING THE OPERATION, WHICH SPONTANEOUSLY RESOLVED AS REVEALED BY CHEST X-RAY. ADDITIONALLY FOUR PATIENTS DEVELOPED SUBCUTANEOUS OR MEDIASTINAL EMPHYSEMA AS POSTOPERATIVE COMPLICATIONS, WHICH WERE MANIFESTED BY POSTOPERATIVE X-RAY OR CT SCANS. ONE OF FOUR PATIENTS DEVELOPED FEVER AND SYMPTOMS OF PNEUMONIA, HOWEVER, RECOVERED AFTER ANTIBIOTICS ADMINISTRATION. FURTHER DETAILED INFORMATION COULD NOT BE OBTAINED FROM THE USER FACILITY AT PRE

  Patient problems: Fever; Injury; Pneumonia

  MAUDE report 9760709 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "PERORAL ENDOSCOPIC MYOTOMY IN CHILDREN WITH ACHALASIA: A RELATIVELY LONG-TERM SINGLE-CENTER STUDY". THE LITERATURE REPORTED THE RESULT OF 21 CASES OF THE PERORAL ENDOSCOPIC MYOTOMY (POEM) USING OLYMPUS MODEL UCR BETWEEN OCTOBER, 2014 AND OCTOBER, 2016. IN THE 21 CASES OF THE POEM, THE SIX PATIENTS DEVELOPED COMPLICATIONS. THE FIRST PATIENT WHO WAS (B)(6) GIRL, DEVELOPED SUBCUTANEOUS EMPHYSEMA AND PNEUMOPERITONEUM, WHICH MANIFESTED AS SUBCUTANEOUS EMPHYSEMA IN THE HEAD, NECK, ANTERIOR CHEST, AND EMPHYSEMA IN THE ABDOMEN DURING THE OPERATION. THIS PATIENT RECEIVED ABDOMINOCENTESIS AND HER EMPHYSEMA RECOVERED. THE SECOND PATIENT DEVELOPED SUBCUTANEOUS AND MEDIASTINAL EMPHYSEMA DURING THE OPERATION, WHICH SPONTANEOUSLY RESOLVED AS REVEALED BY CHEST X-RAY. ADDITIONALLY FOUR PATIENTS DEVELOPED SUBCUTANEOUS OR MEDIASTINAL EMPHYSEMA AS POSTOPERATIVE COMPLICATIONS, WHICH WERE MANIFESTED BY POSTOPERATIVE X-RAY OR CT SCANS. ONE OF FOUR PATIENTS DEVELOPED FEVER AND SYMPTOMS OF PNEUMONIA, HOWEVER, RECOVERED AFTER ANTIBIOTICS ADMINISTRATION. FURTHER DETAILED INFORMATION COULD NOT BE OBTAINED FROM THE USER FACILITY AT PRESENT. ACCO

  Patient problems: Injury

  MAUDE report 9760707 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "PERORAL ENDOSCOPIC MYOTOMY IN CHILDREN WITH ACHALASIA: A RELATIVELY LONG-TERM SINGLE-CENTER STUDY". THE LITERATURE REPORTED THE RESULT OF 21 CASES OF THE PERORAL ENDOSCOPIC MYOTOMY (POEM) USING OLYMPUS MODEL UCR BETWEEN (B)(6) 2014 AND (B)(6) 2016. IN THE 21 CASES OF THE POEM, THE SIX PATIENTS DEVELOPED COMPLICATIONS. THE FIRST PATIENT WHO WAS (B)(6)-OLD GIRL, DEVELOPED SUBCUTANEOUS EMPHYSEMA AND PNEUMOPERITONEUM, WHICH MANIFESTED AS SUBCUTANEOUS EMPHYSEMA IN THE HEAD, NECK, ANTERIOR CHEST, AND EMPHYSEMA IN THE ABDOMEN DURING THE OPERATION. THIS PATIENT RECEIVED ABDOMINOCENTESIS AND HER EMPHYSEMA RECOVERED. THE SECOND PATIENT DEVELOPED SUBCUTANEOUS AND MEDIASTINAL EMPHYSEMA DURING THE OPERATION, WHICH SPONTANEOUSLY RESOLVED AS REVEALED BY CHEST X-RAY. ADDITIONALLY FOUR PATIENTS DEVELOPED SUBCUTANEOUS OR MEDIASTINAL EMPHYSEMA AS POSTOPERATIVE COMPLICATIONS, WHICH WERE MANIFESTED BY POSTOPERATIVE X-RAY OR CT SCANS. ONE OF FOUR PATIENTS DEVELOPED FEVER AND SYMPTOMS OF PNEUMONIA, HOWEVER, RECOVERED AFTER ANTIBIOTICS ADMINISTRATION. FURTHER DETAILED INFORMATION COULD NOT BE OBTAINED FROM THE USER FACILITY AT PRESENT. ACCO

  Patient problems: Injury

  MAUDE report 9760706 ↗
• InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WE RECEIVED THE FOLLOWING REPORT. *BECAUSE OF "CARDIAC PART SUBMUCOUS EMINENT LESIONS ", THE PATIENT NEEDED TO BE PERFORMED ESD(ENDOSCOPIC SUBMUCOSAL DISSECTION). BECAUSE THE LESION WAS DEEP, EFTR(ENDOSCOPIC FULL THICKNESS RESECTION) WAS PERFORMED. DURING THE OPERATION, THE SUBJECT DEVICE WAS USED. THE DEVICE MALFUNCTION THAT THE STOMACH CANNOT BE INFLATED DUE TO LOW GAS OUTPUT OCCURRED. HAD NO CHOICE BUT TO USE AIR INSTEAD OF CARBON DIOXIDE TO INFLATE THE STOMACH. IT COULD BE CAUSED TO PNEUMOTHORAX AND MEDIASTINAL EMPHYSEMA DURING THE OPERATION AND AFTER THE OPERATION. ENDOTRACHEAL INTUBATION COULD NOT BE PULLED OUT. THE PATIENT WAS TRANSFERRED TO ICU FOR FURTHER TREATMENT AND CLOSED DRAINAGE OF THE LEFT THORACIC CAVITY WAS PERFORMED. THIS WAS AN UNINTENDED ADDITIONAL TREATMENT. THE ENDOTRACHEAL INTUBATION WAS PULLED OUT THE NEXT DAY, AND THE PATIENT WAS TRANSFERRED FROM ICU TO THE DEPARTMENT OF GASTROENTEROLOGY. THE PATIENT IS NOW RECOVERING WELL. THE EVENT WAS ACCIDENTAL, AND THE CAUSE OF THE FAULT IS NOT CLEAR. THE FACTORY ENGINEER CAME TO THE HOSPITAL FOR INSPECTION FOR 3 TIMES, BUT NO FAULT CAUSE WAS FOUND.

  Patient problems: No Code Available

  MAUDE report 8854254 ↗