MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-08-20 for HUDSON POCKET PEAK FLOW METER 1801 manufactured by Teleflex.
[20105278]
The complaint is reported as: the customer alleges that the pocket peak flow meter is giving an inaccurate reading. The pt's condition is reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[20386371]
The sample was not available for eval, therefore, the complaint could not be confirmed. Based on similar complaints in the past, however, a capa was opened by the vendor of the pocket peaks to address the issue with inaccurate readings. The vendor also reported that additional checks were made on the mold in late 2013, and it was verified that the assembly process was not changed or modified. Prior to release, the units must meet mfg criteria and they are 100% tested before leaving the facility. The vendor also reports that in (b)(4) 2014 the formulation of the polypropylene material used for the blue measurement indicator on the packet peaks was changed. The change does not affect the fit, form, function, appearance, or safety of the pocket peaks. The material change was made to improve the consistency of the blue measurement indicator. If the sample is returned, a follow-up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2014-00256 |
| MDR Report Key | 4062911 |
| Report Source | 06,07 |
| Date Received | 2014-08-20 |
| Date of Report | 2014-08-08 |
| Date of Event | 2014-08-04 |
| Date Mfgr Received | 2014-08-08 |
| Date Added to Maude | 2014-09-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334854 |
| Manufacturer Street | 2917 WECK DR. |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON POCKET PEAK FLOW METER |
| Generic Name | PEAK FLOW METER |
| Product Code | BZH |
| Date Received | 2014-08-20 |
| Catalog Number | 1801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-20 |