MAUDE Adverse Event Report: TELEFLEX HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL RA

Catalog Number 1801

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the device is indicating an inaccurate reading when used by the pt.No report of pt injury.

Manufacturer Narrative

The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.

• Brand Name: HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL RA
• Type of Device: PEAK FLOW METER
• Manufacturer (Section D): TELEFLEX; research triangle park NC 27709
• Manufacturer (Section G): TELEFLEX; 2917 weck dr.; research triangle park NC 27709
• Manufacturer Contact: margie burton ; po box 12600; rtp, NC 27709 ; 9194334965
• MDR Report Key: 4132993
• MDR Text Key: 4950267
• Report Number: 1044475-2014-00274
• Device Sequence Number: 1
• Product Code: BZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2012
• Device Catalogue Number: 1801
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1