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

Catalog Number 1801

Device Problems Incorrect Measurement (1383); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2014

Event Type  malfunction  

Event Description

The complaint is reported as: the customer alleges that the peak flow meter is not measuring flow on the patient's expiratory volume.The flow indicator sticks and sometimes the flow arrows falls off.Another device was used on the patient.The patient's condition is reported as fine.

Manufacturer Narrative

The device sample was not returned for evaluation 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; rtp NC 27709
• Manufacturer (Section G): TELEFLEX; 2917 weck drive
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; rtp, NC 27709 ; 9194334965
• MDR Report Key: 3837844
• MDR Text Key: 19407977
• Report Number: 1044475-2014-00099
• 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: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1