BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBLVAC WC

    MDR report key: 1699266 · Received May 7, 2010

    Report

    Report Number
    1419185-2010-14602
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    April 26, 2010
    Report Date
    May 7, 2010
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    OMP
    PMA / PMN Number
    K081185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE WAS DEEMED AS CATASTROPHIC; HOWEVER, EXCEPT AS NOTED ABOVE, NO INJURY WAS REPORTED TO THE OPERATOR, BYSTANDERS OR PT CONNECTED TO THE DEVICE. THE OPERATOR (NURSE) STATED THAT THE DEVICE WAS PLUGGED INTO WALL POWER, AND THE SALES REP INFORMED OMC THAT THE UNIT WAS TESTED PRIOR TO DELIVERY TO THE FACILITY AND THAT NO ABNORMAL OPERATION WAS NOTED. DUE TO THE EXTREME NATURE OF THIS FAILURE, AN IMMEDIATE AND ONGOING INVESTIGATION COMMENCED. THE UNIT WAS IDENTIFIED AS OHIO MEDICAL CORPORATION'S NEGATIVE PRESSURE WOUND THERAPY SUCTION UNIT (769000) (B) (4), WHICH WAS SHIPPED TO (B) (4) ON 4/19/2010. THE UNIT WAS MANUFACTURED IN AUGUST, 2009 BY (B) (4)., WHICH IS OHIO MEDICAL CORPORATION'S SUB SUPPLIER FOR THIS DEVICE. UNIT (B) (4) WAS TESTED AT OMC ON 12/31/09 UNDER LOT NPT091038. THE UNIT PASSED ALL TESTING AND WAS RELEASED FOR DISTRIBUTION BY OMC'S QUALITY ASSURANCE DEPARTMENT ON 12/31/09. THE UNIT WAS IMMEDIATELY SHIPPED FROM (B) (6) HEALTH AND REHAB IN (B) (6), TO THE (B) (6) HEADQUARTERS IN (B) (6). OHIO MEDICAL ENGINEERING SPECIALIST, (B) (4), TRAVELLED TO (B) (6) HEADQUARTERS ON 4/28/10 IN ORDER TO WORK DIRECTLY WITH (B) (6) PERSONNEL DURING THE PRELIMINARY INVESTIGATION. THE FOLLOWING OBSERVATIONS AND TESTS WERE CONDUCTED FROM (B) (6) 2010 TO (B) (6) 2010: THE PACKAGE CONTAINING THE SUBJECT DEVICE WAS RECEIVED AT THE (B) (6) FACILITY THE MORNING OF 04/28/10. THE PACKAGE WAS OPENED AND ITS CONTENTS WERE CAREFULLY UNPACKED, TO PRESERVE ANY EVIDENCE OF THE EXPLOSION. THE CONTENTS WERE ALSO PHOTOGRAPHED IN SUPPORT OF THIS INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED OF THE UNIT, WHICH NOTED THAT THE UNIT WAS BADLY DAMAGED, AND THAT THE INTERNAL VACUUM PUMP HAD BEEN PROPELLED THROUGH THE FRONT OF THE UNIT. THE UNIT CONTAINED A LARGE CRACK ON THE FRONT LEFT PORTION OF THE HOUSING, AND THE LCD/TFT DISPLAY WAS HEAVILY DAMAGED. AFTER A THOROUGH EXAMINATION OF THE EXTERIOR OF THE RETURNED DEVICE, THE HOUSING WAS OPENED UP TO INSPECT THE INTERNAL COMPONENTS. THE INTERIOR EXAMINATION FOUND THAT THE PUMP HAD BEEN SEVERED FROM ITS FOUR TAB MOUNTS, AND THAT THE MOUNTS WERE STILL ATTACHED TO THE REAR HOUSING. IT IS ASSUMED THAT FORWARD MOTION OF THE PUMP DAMAGED THE CIRCUIT BOARD, HOUSING, AND MEMBRANE SWITCH PANEL. THE BATTERY DID NOT SHOW ANY EVIDENCE OF DAMAGE. THE PRINTED CIRCUIT BOARD WAS ALSO EXAMINED FOR SIGNS OF FAILURE. ONE COMPONENT WAS FOUND TO BE PRESSED OUT OF POSITION. NO OTHER CIRCUIT BOARD ANOMALIES WERE NOTED SUCH AS BURNS, POOR SOLDER JOINTS, CRACKS, MISSING COMPONENTS OR FOUL ODOR. THE CIRCUIT BOARD ASSEMBLY APPEARED TO BE IN BRAND NEW CONDITION OTHER THAN THE FACT THAT THE LCD/TFT SCREEN WAS MISSING. FOLLOWING THE VISUAL INSPECTION OF ALL THE MAJOR INTERNAL ELECTRO-MECHANICAL COMPONENTS, A THOROUGH EVAL OF THE INTERNAL PORTION OF THE HOUSING AND UNIT WIRING WAS CONDUCTED. DUE TO THE FORCE OF THE EXPLOSION, THE UNIT WAS INSPECTED FOR ANY EVIDENCE OF HEAT DAMAGE OR FIRE. THE EVAL NOTED NO APPARENT EVIDENCE OF FIRE, CARBON RESIDUE, PLASTIC DEFORMATION DUE TO HEAT DISTRESS, OR TOXIC CHEMICAL. THE INITIAL FINDINGS OF THIS EVAL DID NOT IDENTIFY ANY DEFINITIVE EVIDENCE THAT THE EXPLOSION WAS CAUSED BY FAULTY INTERNAL COMPONENTS. THE UNIT DID NOT EXHIBIT ANY SIGNS OF ELECTRICAL MALFUNCTION, OVERHEATING, IMPROPER ASSEMBLY, BATTERY FAILURE, OR FIRE. FURTHER INVESTIGATION INTO POSSIBLE FLAMMABLE MATERIALS, AMONG OTHER CAUSES, PRESENT AT THE SITE ARE BEING CONSIDERED BY OHIO MEDICAL CORPORATION. A FUNCTIONAL INSPECTION WAS PERFORMED IN ORDER TO ASSESS THE FUNCTIONAL CONDITION OF THE COMPONENTS FROM THE SUBJECT DEVICE. A FULLY FUNCTIONAL, VALIDATED NPWT UNIT WAS USED AS THE CONTROL UNIT FOR THE PURPOSES OF THE FUNCTIONAL INSPECTIONS. THE FIRST COMPONENT FROM THE SUBJECT DEVICE THAT WAS EVALUATED WAS THE BATTERY. PRIOR TO INSERTION OF THE BATTERY FROM THE SUBJECT DEVICE INTO THE CONTROL UNIT, THE BATTERY WAS MEASURED USING A DIGITAL MULTIMETER AND WAS FOUND TO MEASURE 13.1 VDC. THE BATTERY WAS THEN CONNECTED TO THE CONTROL UNIT AND THE POWER UP SEQUENCE WAS INITIATED. THE UNIT FUNCTIONED WITHIN SPECIFICATIONS USING THE BATTERY FROM THE SUBJECT DEVICE, AND THE BATTERY DISPLAY ON THE LCD/TFT SCREEN INDICATED A "GREEN" CONDITION. A "GREEN" CONDITION INDICATES THAT THE BATTERY WAS FULLY CHARGED, AND FUNCTIONING NORMALLY. PRIOR TO CONNECTION OF THE DC POWER SUPPLY TO THE UNIT, THE POWER SUPPLY WAS CONNECTED TO THE POWER STRIP SUPPLIED BY THE HOSPITAL THAT THE SUBJECT UNIT WAS PLUGGED INTO AT THE TIME THE INCIDENT OCCURRED. THE VOLTAGE MEASUREMENT WAS TAKEN DIRECTLY AT THE POWER SUPPLY OUTPUT PORT, AND IT WAS FOUND TO BE SUPPLYING 24.1 VDC WHICH IS WITHIN THE NORMAL RANGE OF 23-25 VDC. THE RETURNED POWER SUPPLY WAS THEN CONNECTED TO THE UNIT AND THE DISPLAY IMMEDIATELY SHOWED THE "PLUG" ICON, AT WHICH TIME THE BATTERY DISPLAY IMMEDIATELY BEGAN TO ASCEND, INDICATING THAT THE BATTERY HAD BEGUN TO CHARGE. THE ABOVE MENTIONED CONDITIONS ARE ALL EXPECTED AND WITHIN NORMAL OPERATING PARAMETERS FOR THIS DEVICE. ONCE THE CONTROL UNIT WAS OBSERVED TO BE OPERATING NORMALLY, THE PUMP FROM THE CONTROL WAS REPLACED WITH THE PUMP FROM THE SUBJECT DEVICE. THE POWER UP SEQUENCE WAS RE-INITIATED AND THE UNIT OPERATED WITHIN SPECIFICATIONS. THE CIRCUIT BOARD COULD NOT BE EVALUATED IN THE CONTROL UNIT DUE TO A DAMAGED COMPONENT. THE CIRCUIT BOARD WILL BE EVALUATED AT OMC HEADQUARTERS WHERE THE DAMAGED COMPONENT WILL BE REPLACED ON THE BOARD AND THEN FUNCTIONALLY TESTED. AFTER ALL THE AVAILABLE COMPONENTS WERE REPLACED IN THE CONTROL UNIT, THE UNIT WAS ALLOWED TO OPERATE IN THERAPY MODE FOR APPROXIMATELY SIX (6) HOURS. DURING THIS TIME, THE VOLTAGE AND TEMPERATURE OF THE BATTERY WERE OBSERVED. VOLTAGE AND TEMPERATURE READINGS WERE ALL OBSERVED TO BE WITHIN EXPECTED NORMAL RANGES DURING OPERATION. BASED ON THIS TESTING, THE PUMP, BATTERY, AND POWER SUPPLY FROM THE SUBJECT UNIT WERE ALL FOUND TO BE OPERATING AS EXPECTED AND WITHIN SPECIFICATIONS. EXTENDED TESTING WILL BE CONDUCTED AT OMC ONCE THE CIRCUIT BOARD IS REPAIRED, AS WELL AS ANY ADDITIONAL TESTING AND ANALYSIS THAT WOULD BE NEEDED TO DETERMINE THE ROOT CAUSE OF THIS INCIDENT. THE CANISTER FROM THE SUBJECT DEVICE INVOLVED IN THE INCIDENT, IN ADDITION TO A CONTROL CANISTER, WERE SENT TO AN OUTSIDE LABORATORY FOR ANALYSIS. THE POLYMER CANISTERS WILL BE EVALUATED FOR POSSIBLE RESIDUAL ORGANIC CONTAMINATION BY GAS CHROMOTOGRAPHY/MASS SPECTROSCOPY. THE EVAL WILL BE PERFORMED USING SOLID PHASE MICRO EXTRACTION ON EACH CANISTER'S CHARCOAL FILTER, AND A SOLVENT RINSE ANALYSIS OF EACH CANISTER'S WALL. DETAILS OF THIS CHEMICAL EVAL AND THE RESULTS WILL BE PRESENTED IN THE FOLLOW-UP REPORT FOR THIS INCIDENT. FURTHERMORE, AT OMC'S REQUEST, ENGINEERING AND ROOT CAUSE EXPERTS HAVE BEEN CONTACTED TO REVIEW THE PRELIMINARY INVESTIGATION RESULTS, THE SUBJECT DEVICE AND ITS COMPONENTS, IN ADDITION TO THE CHEMICAL ANALYSIS AT THE OMC FACILITY TO ASSIST IN THE DETERMINATION OF ROOT CAUSE. DETAILS OF THIS EVAL AND ANY ADDITIONAL TESTING CONDUCTED IN SUPPORT OF THE INVESTIGATION NOT MENTIONED IN THIS INITIAL REPORT WILL BE PRESENTED IN THE FOLLOW-UP REPORT FOR THIS INCIDENT.

    Description of Event or Problem · 1

    ON (B) (6) 2010, OHIO MEDICAL CORPORATION (OMC), RECEIVED A COMPLAINT FROM (B) (6) OF (B) (4) MEDICAL DEVICES, AN INDEPENDENT (B) (4) SALES REP, REGARDING A NEGATIVE PRESSURE WOUND THERAPY SUCTION UNIT (769600) THAT WAS ALLEGEDLY INVOLVED IN AN EXPLOSIVE EVENT DURING ITS INITIAL USE AT (B) (6) FACILITY IN (B) (6), (B) (6). THE CAUSE OF THE EVENT IS UNDER INTENSIVE INVESTIGATION. AFTER THE CALL WAS RECEIVED, THE SALES REP RETURNED TO THE FACILITY WHERE THE FAILURE OCCURRED AND COLLECTED PHOTOGRAPHIC EVIDENCE AND WRITTEN STATEMENTS FROM THE NURSE WHO WAS ADMINISTERING THERAPY, THE CNA, AND THE PT, ALL WHOM WITNESSED THE EVENT. IT HAS BEEN REPORTED THAT THE PT HAD TWO WOUNDS (ABDOMINAL AND SACRAL) AND A COLOSTOMY BAG. THE COLOSTOMY BAG WAS LOCATED AT A 2 O'CLOCK POSITION FROM THE ABDOMINAL WOUND. NEGATIVE PRESSURE WOUND THERAPY (NPWT) WAS TO BE USED TO CLOSE BOTH WOUNDS ON THE PT. THE NPWT DEVICE WAS LOCATED ON THE BEDSIDE TABLE, TO THE RIGHT OF THE PT AT HEAD LEVEL. THE DEVICE WAS FACING AWAY FROM THE PT, TOWARDS THE LEFT SIDE OF THE WOUND CARE NURSE. THE WOUND CARE NURSE WAS USING TUBING WITH A "T" CONNECTOR SO THAT ONE COLLECTION CANISTER COULD BE ATTACHED TO BOTH LOCATIONS. THE TUBING DID NOT CONTAIN CLAMPS TO CLOSE OFF EITHER SIDE OF THE "T". THE NURSE STATED THAT AT APPROX 8:15 PM ON (B) (6) 2010, SHE WAS IN THE ROOM WITH THE PT CHANGING THE WOUND DRESSINGS AND COLOSTOMY. THE PT WAS LAYING ON HIS RIGHT SIDE DURING THE PROCEDURE. THE NURSE STATED THAT AT APPROX 8:58 PM ONCE THE ABDOMINAL WOUND DRESSING WAS COMPLETED, SHE TURNED ON THE NPWT DEVICE BY TOUCHING THE BUTTON ON THE BOTTOM OF THE DEVICE'S SCREEN TO ACTIVATE THE SCREEN, AT WHICH TIME SHE TOUCHED THE "RUN" BUTTON. THE NURSE THEN COVERED THE UNCONNECTED END OF THE "T" CONNECTOR WITH HER THUMB TO GET A SEAL ON THE ABDOMINAL WOUND. THE UNCONNECTED END OF THE "T" WAS OPEN TO THE ENVIRONMENT WHEN THE VACUUM PRESSURE STARTED UNTIL IT WAS COVERED BY THE NURSE. THE SACRAL WOUND WAS NOT YET DRESSED AT THE TIME OF THE INCIDENT. THE DEVICE BEGAN TO APPLY VACUUM PRESSURE TO THE WOUND AND THEN TURNED OFF. THE NURSE STATED THAT THE WOUND DRESSING HAD NO AIR LEAKS. APPROX 5 SECONDS LATER, THE DEVICE TURNED BACK ON, APPLYING VACUUM, AND THEN INSTANTLY TURNED OFF AND THEN BACK ON AGAIN. ACCORDING TO THE NURSE, IT WAS AT THAT MOMENT WHEN THE DEVICE TURNED BACK ON, THAT THE DEVICE EXPLODED. THE NURSE WAS STANDING APPROX 2 1/2 FEET FROM THE DEVICE WITH HER BACK TO IT WHEN THE EXPLOSION OCCURRED AND REPORTED A SCRATCH AND BRUISING ON HER LOWER BACK. THE NURSE REPORTED THAT ALL PERSONS IN THE ROOM WERE HAVING DIFFICULTIES HEARING AFTER THE INCIDENT. THE NURSE CHECKED ON THE PT AND STATED THAT HE WAS FINE, JUST SCARED. THE CNA STATED THAT WHEN THE DEVICE EXPLODED, PIECES OF THE DEVICE WERE CAST THROUGHOUT THE ROOM. THE PT ADDED THAT THERE WAS A BURNT SMELL IN THE ROOM AFTER THE EXPLOSION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBLVAC WC NEGATIVE PRESSURE WOUND THERAPY UNIT OMP OHIO MEDICAL CORPORATION 769600 NPT091038

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other SACRAL WOUND| COLOSTOMY| ABDOMINAL WOUND| NEGATIVE PRESSURE WOUND THERAPY