MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for AIRFLOW AF1140MB manufactured by Sunmed Holdings Llc..
[139991736]
The affected product was not returned. Functional evaluation of the product found no issues for existing inventory, although the reported lot was not available. A lookback at resus bags for the past two years shows 1 complaint for masks getting stuck to the port of the resus bag. Over the last 2 years there have been 0 nc's related to masks getting stuck to the port of the resus bags. There is no available evidence to support there is a product issue form this complaint.
Patient Sequence No: 1, Text Type: N, H10
[139991737]
The customer alleges the " mask would not disconnect from the resus bag". No other details were provided and no patient injury/harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314417-2019-00010 |
| MDR Report Key | 8452320 |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-26 |
| Date of Event | 2018-09-01 |
| Date Added to Maude | 2019-03-26 |
| 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 | RESUS BAG |
| Product Code | BTM |
| Date Received | 2019-03-26 |
| Model Number | AF1140MB |
| 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 | 2019-03-26 |