MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-03-08 for HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER 8884717301 manufactured by Teleflex Medical.
[69365402]
(b)(4). A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report. A device history record investigation did not show issues related to this complaint. A record assessment (fmea) was conducted and no changes required. Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect, and determine a root cause. Customer complaint cannot be confirmed. Root cause is unknown. If the device sample becomes available at a later date, this complaint will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[69365403]
Customer complaint alleges that "during use, the ball (or "the balls") in cylinder didn't move properly. Therefore, a new unit was used instead". No patient harm reported. Patient's condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
[74716736]
(b)(4). The sample was returned for evaluation. The returned breathing exerciser was visually examined and no defects or anomalies were observed. A functional inspection was performed on the returned breathing exerciser to simulate use. The exerciser was connected to a vacuum flowmeter to test for movement of the inner balls. All three inner balls were able to move within the breathing exerciser at a pressure that was within the acceptable tolerance for each ball. No functional issues were found. The instructions for use (ifu) for this product were reviewed as a part of this complaint investigation. The ifu instructs the end user, "inhale at a sufficient rate to raise only the ball in the first chamber, while the ball in the second chamber remains at rest. For a higher flow rate, inhale at a rate sufficient to raise the first and second balls, while the ball in the third chamber remains at rest. " other remarks: the reported complaint of "balls stuck in cylinder" was not confirmed based upon the sample received. The returned breathing exerciser was able to pass a functional inspection when connected to a vacuumed air. All three inner balls were able to move within the breathing exerciser when the flowmeter was set to a pressure within the acceptable tolerance of each ball. There were no functional issues found with the returned sample.
Patient Sequence No: 1, Text Type: N, H10
[74716737]
Customer complaint alleges that "during use, the ball (or "the balls") in cylinder didn't move properly. Therefore, a new unit was used instead". No patient harm reported. Patient's condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2017-00178 |
| MDR Report Key | 6387148 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-08 |
| Date of Report | 2017-03-01 |
| Date of Event | 2017-02-23 |
| Date Mfgr Received | 2017-05-08 |
| Device Manufacturer Date | 2016-06-21 |
| Date Added to Maude | 2017-03-08 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER |
| Generic Name | SPIROMETER, THERAPUETIC |
| Product Code | BWF |
| Date Received | 2017-03-08 |
| Returned To Mfg | 2017-04-11 |
| Catalog Number | 8884717301 |
| Lot Number | 73F1600455 |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-03-08 |