MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-03-25 for HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL RA 1801 manufactured by Teleflex.
[4499901]
The complaint is reported as: the customer alleges that when the pt blows into the peak flow meter the blue indicator moves very easily. The pt barely breathes in to the meter and the blue indicator moves to the high end of the scale with very little pressure. The device was changed out for another one. No pt harm reported.
Patient Sequence No: 1, Text Type: D, B5
[11891211]
The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2014-00075 |
| MDR Report Key | 3815848 |
| Report Source | 06 |
| Date Received | 2014-03-25 |
| Date of Report | 2014-03-12 |
| Date of Event | 2014-03-06 |
| Date Mfgr Received | 2014-03-12 |
| Date Added to Maude | 2014-06-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | 2917 WECK DR. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL RA |
| Generic Name | PEAK FLOW METER (SPIROMETRY |
| Product Code | BZH |
| Date Received | 2014-03-25 |
| Catalog Number | 1801 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-25 |