MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-13 for VENTLAB HYPERINFLATION BAG SYSTEM WITH MANOMETER HS4051 manufactured by Ventlab Llc..
[48252898]
The customer returned one 2l hyperinflation bag, two 1l hyperinflation bags, one 0. 5l hyperinflation bag, 4 manometers and 2 masks. Both masks were manufactured by vital signs. Two of the manometers had the exhalation port broken off and stuck in the masks. One manometer was normal. The fourth manometer had been assembled to a hyperinflation bag incorrectly. The bag was attached to the exhalation port. When the hyperinflation bag was removed, the exhalation port on the manometer had some sort of film on it. The two broken exhalation ports were firmly stuck in the masks. They were removed. Both masks and all four exhalation ports were checked with iso gages. The id of the masks and the od of the manometers were all compliant with the iso spec. See accompanying photos. In addition, all four hyperinflation bags where visually checked for holes. None were observed. The two functioning manometers were then tested with the two masks. They were assembled and dissembled multiple times. They functioned as intended. Given that the fit between a manometer and a mask is a friction fit, it is possible to press them together so hard that they cannot be removed. This situation is aggravated by the fact that the exhalation port rotates which makes it harder to remove a stuck mask from a manometer.
Patient Sequence No: 1, Text Type: N, H10
[48252899]
The customer has reported the bag sticks to connectors, tears loose and tears a hole in the bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246980-2016-00011 |
| MDR Report Key | 5721150 |
| Date Received | 2016-06-13 |
| Date of Report | 2016-06-13 |
| Date of Event | 2016-05-06 |
| Date Mfgr Received | 2016-05-06 |
| Device Manufacturer Date | 2015-10-26 |
| Date Added to Maude | 2016-06-13 |
| 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. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal | 49544 |
| Manufacturer Phone | 6162598350 |
| Manufacturer G1 | VENTLAB LLC. |
| Manufacturer Street | 2710 NORTHRIDGEDR. 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 | VENTLAB HYPERINFLATION BAG SYSTEM WITH MANOMETER |
| Generic Name | HYPERINFLATION BAG SYSTEM WITH MANOMETER |
| Product Code | NHK |
| Date Received | 2016-06-13 |
| Returned To Mfg | 2016-05-23 |
| Model Number | HS4051 |
| Lot Number | 303142 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTLAB LLC. |
| Manufacturer Address | 2710 NORTHRIDGEDR. SUITE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-13 |