AMBU SPUR II ADULT TUBE RES
Report
- Report Number
- 1220828-2024-00005
- Event Type
- Malfunction
- Date Received
- April 3, 2024
- Report Date
- May 6, 2024
- Manufacturer
- AMBU A/S
- Product Code
- OEV
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- MI, US
- Reporter Occupation
- 501
Narratives
INITIAL MDR 1220828-2024-00005 REPORTED ON APRIL 3RD, 2024: THE COMPLAINT SAMPLE INVESTIGATION TEAM RECEIVED TWO SAMPLES ON (B)(6) 2024. ONE OF THE SAMPLES WAS FROM ONE OF THE TWO FAILLING AMBU BAGS. BASED ON THE INVESTIGATION PERFORMED AND DOCUMENTED IN COMPLAINT VERFICATION TEST REPORT ONE SPUR II (LOT NUMBER: 1000809723) IS DEFORMED AND COULD NOT RECOIL. OTHER SPUR II (LOT NUMBER: 1000745292) IS IN NORMAL CONDITION AND COULD RECOIL. DISCS IN PATIENT VALVE AND INLET VALVE ARE ASSEMBLED WELL. AFTER MANUFACTURING, A 100% FUNCTION TEST IS PERFORMED TO MAKE SURE THE FINISHED PRODUCT MEETS THE DESIGN SPECIFICATION. AMBU SPUR II HAS BEEN VERIFIED TO BE ABLE TO RE-EXPAND TO ITS DEFAULT SHAPE BY ITSELF AFTER COMPRESSION. SPUR II IS PACKED MANUALLY ACCORDING TO PACKING PROCEDURE. IT IS EASY TO DETECT A DEFORM COMPRESSIBLE BAG DURING PACKING. THEREFORE, A COMPRESSIBLE BAG SHOULD NOT BE DEFORM BEFORE DELIVERY TO CUSTOMER. FURTHERMORE, THE TRANSPORTATION PACKAGE HAS BEEN VERIFIED TO BE ABLE TO MEET TRANSPORTATION REQUIREMENTS FROM THE TEST REPORT. THERE ARE SOME POSSIBLE CAUSES FOR COMPRESSIBLE BAG DEFORMATION, SUCH AS IMPROPER STORAGE BY CUSTOMER OR CARTON BOX UPSIDE DOWN DURING TRANSPORTATION ALTHOUGH THERE IS A MARK ON THE OUTSIDE OF THE CARTON BOX TO INFORM THE OPERATOR HOW TO TURN THE CARTON BOX. AMBU A/S HAS TRIED TO GET MORE INFORMATION FROM THE CUSTOMER ON HOW THE AFFECTED PRODUCT WAS STORED, HOWEVER, NO REPLY WAS RECEIVED FROM CUSTOMER. DUE TO THE LIMITED INFORMATION IN THIS CASE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE INSTRUCTION FOR USE (IFU) STATES "NEVER STORE THE RESUSCITATOR IN A DEFORMED STATE OTHER THAN AS FOLDED WHEN DELIVERED BY MANUFACTURER, OTHERWISE PERMANENT DISTORTION OF THE BAG COULD OCCUR, WHICH MAY REDUCE VENTILATION EFFICIENCY" AND "ALWAYS VISUALLY INSPECT THE PRODUCT AND A FUNCTIONALITY TEST AFTER UNPACKING, ASSEMBLY AND PRIOR TO USE, AS DEFECTS AND FOREIGN MATTER CAN LEAD TO NO OR REDUCED VENTILATION OF THE PATIENT". FOLLOW-UP #1 MDR 1220828-2024-00005 REPORTED MAY 6TH, 2024: APRIL 10TH, 2024 ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE CUSTOMER INFORMED THAT IN ONE OF THE CASES THE RESPIRATORY THERAPIST NOTICED THAT THE BAG WAS COMPRESSED PRIOR TO USE AND THAT IS WAS IDENTIFIED AFTER INVESTIGATION THAT THE BAGS WERE FOUND TO HAVE BEEN STORED IN A COMPRESSED STATE IN THAT SPECIFIC UNIT. BASED ON THIS INFORMATION FROM THE CUSTOMER, THE ROOT CAUSE FOR THE DERFORMED COMPRESSIBLE BAG WAS DETERMINED AS IMPROPER STORAGE BY CUSTOMER. THE INVESTIGATION FINDINGS CODE AND INVESTIGATION CONCLUSIONS CODE IN H6 HAVE BEEN UPDATED ACCORDINGLY FOR THE MANUFACTURER REPORT.
THE COMPLAINT SAMPLE INVESTIGATION TEAM RECEIVED TWO SAMPLES ON 26-MAR-2024. ONE OF THE SAMPLES WAS FROM ONE OF THE TWO FAILLING AMBU BAGS. BASED ON THE INVESTIGATION PERFORMED AND DOCUMENTED IN COMPLAINT VERFICATION TEST REPORT ONE SPUR II (LOT NUMBER:1000809723) IS DEFORMED AND COULD NOT RECOIL. OTHER SPUR II (LOT NUMBER 1000745292) IS IN NORMAL CONDITION AND COULD RECOIL. DISCS IN PATIENT VALVE AND INLET VALVE ARE ASSEMBLED WELL. AFTER MANUFACTURING, A 100% FUNCTION TEST IS PERFORMED TO MAKE SURE THE FINISHED PRODUCT MEETS THE DESIGN SPECIFICATION. AMBU SPUR II HAS BEEN VERIFIED TO BE ABLE TO RE-EXPAND TO ITS DEFAULT SHAPE BY ITSELF AFTER COMPRESSION. SPUR II IS PACKED MANUALLY ACCORDING TO PACKING PROCEDURE. IT IS EASY TO DETECT A DEFORM COMPRESSIBLE BAG DURING PACKING. THEREFORE, A COMPRESSIBLE BAG SHOULD NOT BE DEFORM BEFORE DELIVERY TO CUSTOMER. FURTHERMORE, THE TRANSPORTATION PACKAGE HAS BEEN VERIFIED TO BE ABLE TO MEET TRANSPORTATION REQUIREMENTS FROM THE TEST REPORT. THERE ARE SOME POSSIBLE CAUSES FOR COMPRESSIBLE BAG DEFORMATION, SUCH AS IMPROPER STORAGE BY CUSTOMER OR CARTON BOX UPSIDE DOWN DURING TRANSPORTATION ALTHOUGH THERE IS A MARK ON THE OUTSIDE OF THE CARTON BOX TO INFORM THE OPERATOR HOW TO TURN THE CARTON BOX. AMBU A/S HAS TRIED TO GET MORE INFORMATION FROM THE CUSTOMER ON HOW THE AFFECTED PRODUCT WAS STORED, HOWEVER, NO REPLY WAS RECEIVED FROM CUSTOMER. DUE TO THE LIMITED INFORMATION IN THIS CASE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE INSTRUCTION FOR USE (IFU) STATES "NEVER STORE THE RESUSCITATOR IN A DEFORMED STATE OTHER THAN AS FOLDED WHEN DELIVERED BY MANUFACTURER, OTHERWISE PERMANENT DISTORTION OF THE BAG COULD OCCUR, WHICH MAY REDUCE VENTILATION EFFICIENCY" AND "ALWAYS VISUALLY INSPECT THE PRODUCT AND A FUNCTIONALITY TEST AFTER UNPACKING, ASSEMBLY AND PRIOR TO USE, AS DEFECTS AND FOREIGN MATTER CAN LEAD TO NO OR REDUCED VENTILATION OF THE PATIENT".
THE PATIENT WAS AN INTUBATED PATIENT THAT REQUIRED AMBU BAG VENTILATION DURING A DESATURATION EVENT. TWO AMBU BAGS DID NOT REINFLATE DURING USE (ONE SAVED FOR THE VENDOR THE OTHER WAS DISPOSED OF). NO, ADVERSE EFFECTS WERE NOTED AND THE PATIENT DID RECOVER. THE CUSTOMER HAD TO USE 3 DIFFERENT AMBU BAGS IN ORDER TO FIND ONE THAT REINFLATED PROPERLY. THE CUSTOMER REPORTED THE INCIDENT TO LOCAL REPRESENTATIVE.
THE PATIENT WAS AN INTUBATED PATIENT THAT REQUIRED AMBU BAG VENTILATION DURING A DESATURATION EVENT. TWO AMBU BAGS DID NOT REINFLATE DURING USE (ONE SAVED FOR THE VENDOR THE OTHER WAS DISPOSED OF). NO, ADVERSE EFFECTS WERE NOTED AND THE PATIENT DID RECOVER. THE CUSTOMER HAD TO USE 3 DIFFERENT AMBU BAGS IN ORDER TO FIND ONE THAT REINFLATED PROPERLY. THE CUSTOMER REPORTED THE INCIDENT TO LOCAL REPRESENTATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1758010 | AMBU SPUR II ADULT TUBE RES | AMBU SPUR II ADULT TUBE RES | OEV | AMBU A/S | 1000809723, 1000745292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |