MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-04 for HUDSON 0.5 HYPERINFLATION W/ MANMTR, MASK 5406 manufactured by Teleflex Medical.
[136163458]
(b)(4). The device was received for evaluation. A visual inspection was performed found no signs of any abuse/misuse/damage. Functional testing was conducted as follows: turn the exhalation port valve clockwise until fully open and keep the cap on the patient connector. Connect the gas supply tube to an oxygen flow meter and adjust to 5 lpm. Observe the reading on the manometer; it should be less than 5 cm h2o. Turn the exhalation port valve counter clockwise until fully closed. Observe the reading on the manometer; it should be 25 cm h2o, +/- 5 cm h2o. Adjust the gas flow to 10 lpm. Observe the reading on the manometer; it should read 45 cm h2o +/- 5 cm h2o. (continued) other remarks: 8. Gently squeeze the bag. Observe that the manometer reading increases and decreases during the ventilation cycle. Turn the exhalation port valve clockwise until fully open and keep the cap on the patient connector. Observe the reading on the manometer; it should be less than 5 cm h2o. The device passed all 10 steps of the pre-use functional test. There were no noted discrepancies in the functionality of this product, and no anomalies regarding a valve popping off. Customer complaint is not confirmed. No corrective/preventative actions will be assigned. Teleflex will continue to monitor customer feedback for complaints of this nature.
Patient Sequence No: 1, Text Type: N, H10
[136163459]
Customer complaint alleges the "port pops off too easily". Alleged issue reported found during use. Another device was obtained for use. No patient harm reported. Patient condition reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2019-00031 |
| MDR Report Key | 8301215 |
| Date Received | 2019-02-04 |
| Date of Report | 2019-01-14 |
| Date of Event | 2019-01-11 |
| Date Mfgr Received | 2019-01-14 |
| Date Added to Maude | 2019-02-04 |
| 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 | LINDA WOODALL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9196942566 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HUDSON 0.5 HYPERINFLATION W/ MANMTR, MASK |
| Generic Name | RESUSCITATOR, MANUAL |
| Product Code | NHK |
| Date Received | 2019-02-04 |
| Returned To Mfg | 2019-01-22 |
| Catalog Number | 5406 |
| Lot Number | 180421 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-04 |