MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-05-28 for AIRFLOW AF5140MBS-M5 manufactured by Sunmed Holdings Llc..
[146359000]
Affected product was returned. The exhalation port was confirmed detached from the patient valve. The bv filter was still attached to the exhalation port which confirms that the breakage occurred after assembly. The valve would still be functional, however, the bv filter would not be usable with the resuscitation bag. Customer complaint was confirmed.
Patient Sequence No: 1, Text Type: N, H10
[146359001]
The customer alleges the "exhalation port was broken off. " no other details were provided and no patient injury/harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314417-2019-00033 |
| MDR Report Key | 8645507 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-09 |
| Date of Event | 2019-05-02 |
| Date Added to Maude | 2019-05-28 |
| 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 | 3 |
| Brand Name | AIRFLOW |
| Generic Name | MANUAL RESUSCITATOR |
| Product Code | BTM |
| Date Received | 2019-05-28 |
| Returned To Mfg | 2019-05-15 |
| Model Number | AF5140MBS-M5 |
| Lot Number | 317561 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-28 |