MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2001-02-09 for AMBU E-VALVE 000 023 000 manufactured by Ambu International A/s.
[235788]
"at a hosp an intubated pt was connected to a ambu e valve which was equipped with 3 shutters instead of 2. Due to the extra shutter the pt could not breathe normally or be ventilated in the right way. The third shutter was placed after the sterilization in the 22 mm inner diameter of the inlet connector. If it had been placed by a person who didn't know how to assemble such a valve or that by accident the shutter fell down into the inlet is unknown at this moment. The pt suffered of pneumonia and therefore showed difficulty to breath due to secretion in their airway. The medical staff tried several times to clean the airway with a suction device, but each time they connected the pt to the valve, the breathing became difficult. The origin of the obstruction (in this case the valve) has been discovered after the death of the pt by the new staff shift. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610691-2001-00001 |
| MDR Report Key | 316186 |
| Report Source | 01,06,08 |
| Date Received | 2001-02-09 |
| Date of Report | 2001-02-09 |
| Date of Event | 2000-11-08 |
| Date Mfgr Received | 2000-11-15 |
| Date Added to Maude | 2001-02-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MR. POUL OTTOSEN, QM |
| Manufacturer Street | SDR. RINGVEJ 49 POB 215 |
| Manufacturer City | BRONDBY DK 2605 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK 2605 |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMBU E-VALVE |
| Generic Name | NON-RE-BREATHING VALVE |
| Product Code | CBP |
| Date Received | 2001-02-09 |
| Model Number | AMBU E-VALVE |
| Catalog Number | 000 023 000 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 305742 |
| Manufacturer | AMBU INTERNATIONAL A/S |
| Manufacturer Address | SDR RINGVEJ 49 POB 215 BRONDBY DA DK-2605 |
| Baseline Brand Name | AMBU E-VALVE |
| Baseline Generic Name | NON-RE-BREATHING VALVE |
| Baseline Model No | AMBU E-VALVE |
| Baseline Catalog No | 000 023 000 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2001-02-09 |