MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-16 for SPUR? II ADULT RESUSCITATORSINGLE PATIENT USE RESUSCITATOR 521611001 manufactured by Ambu A/s.
[175216796]
Respiratory therapist entered room of cardiac arrest patient to find patient being mask/ bag ventilated with plastic still over air mask bag unit mask. Plastic was removed and ventilation was resumed. Manufacturer response for air mask bag unit bag, (brand not provided) (per site reporter). The manufacturer is now no longer individually wrapping the mask to prevent this from occurring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9595927 |
| MDR Report Key | 9595927 |
| Date Received | 2020-01-16 |
| Date of Report | 2019-12-31 |
| Date of Event | 2019-12-06 |
| Report Date | 2019-12-31 |
| Date Reported to FDA | 2019-12-31 |
| Date Reported to Mfgr | 2020-01-16 |
| Date Added to Maude | 2020-01-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPUR? II ADULT RESUSCITATORSINGLE PATIENT USE RESUSCITATOR |
| Generic Name | VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) |
| Product Code | BTM |
| Date Received | 2020-01-16 |
| Model Number | 521611001 |
| Catalog Number | 521611001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMBU A/S |
| Manufacturer Address | 6230 OLD DOBBIN LN STE 250 COLUMBIA MD 21045 US 21045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-16 |