MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-11 for AIRFLOW AF3140MB manufactured by Sunmed Holdings Llc..
[143601832]
A review of the batch record was performed and no abnormalities were noted. No rejects or inspection notes on the o2 port condition were observed. The affected device was not returned however a picture was provided. Visual inspection of the affected product through provided picture did confirm that the o2 port on the tail valve was broken.
Patient Sequence No: 1, Text Type: N, H10
[143601833]
The customer alleges the "ambu bag on peds malfunctioned''. No other details were provided and no patient injury/harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314417-2019-00016 |
| MDR Report Key | 8505610 |
| Date Received | 2019-04-11 |
| Date of Report | 2019-04-11 |
| Date of Event | 2019-03-11 |
| Date Added to Maude | 2019-04-11 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CARRIE FORTUNA |
| Manufacturer Street | 2710 NORTHRIDGE DR. NW. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal | 49544 |
| Manufacturer Phone | 6162598400 |
| Manufacturer G1 | SUNMED HOLDINGS, LLC. |
| Manufacturer Street | 2710 NORTHRIDGE DR. NW. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AIRFLOW |
| Generic Name | RESUSCITATOR |
| Product Code | BTM |
| Date Received | 2019-04-11 |
| Model Number | AF3140MB |
| Lot Number | 316974 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNMED HOLDINGS LLC. |
| Manufacturer Address | 2710 NORTHRIDGE DR. NW SUITE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-11 |