MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-20 for PERCUSSIONAIRE A50521-D manufactured by Percussionaire Corp..
[73517856]
B10999-d retainer ring installed upside down so that it would not form a seal around the b10750 check valve flapper, thus allowing some air to escape in the wrong direction through the check valve. All employees responsible for assembling parts with flappers will be re-trained to ensure the parts are assembled correctly. A test method was developed to allow 100% testing of the flapper valve for leaks.
Patient Sequence No: 1, Text Type: N, H10
[73517857]
(customer complaint # 0798) issues with a cone on patient, experiencing loss of set tidal volumes. Respiratory therapist had to exchange cone out times 3. Respiratory therapist kept one. Did not see any visible cracks. Per giles no harm to the patient incurred. Events are as follows: respiratory therapist using ipv in line, wye was replaced with the cone, respiratory therapist observed loosing 250 ml per breath, when the regular wye was reinstalled the volume came back. Respiratory therapist determined cause to be a leak in the cone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000524541-2017-00001 |
| MDR Report Key | 6509277 |
| Date Received | 2017-04-20 |
| Date of Report | 2017-04-20 |
| Date of Event | 2017-04-01 |
| Date Mfgr Received | 2017-04-03 |
| Device Manufacturer Date | 2016-06-07 |
| Date Added to Maude | 2017-04-20 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHARLES MOORE |
| Manufacturer Street | 1655 GLENGARY BAY RD. |
| Manufacturer City | SAGLE ID 83860 |
| Manufacturer Country | US |
| Manufacturer Postal | 83860 |
| Manufacturer Phone | 2082632549 |
| Manufacturer G1 | PERCUSSIONAIRE CORP. |
| Manufacturer Street | 1655 GLENGARY BAY RD. |
| Manufacturer City | SAGLE ID 83860 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 83860 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PERCUSSIONAIRE |
| Generic Name | CONE ASSEMBLY, BLUE, LEXAN (ACCESSORY TO IPV-1C OR IPV-2C) |
| Product Code | NHJ |
| Date Received | 2017-04-20 |
| Returned To Mfg | 2017-04-12 |
| Model Number | A50521-D |
| Catalog Number | A50521-D |
| Lot Number | WO30702 OR WO30960 |
| Operator | RESPIRATORY THERAPIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERCUSSIONAIRE CORP. |
| Manufacturer Address | 1655 GLENGARY BAY RD SAGLE ID 83860 US 83860 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-20 |