MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON-RCI VOLDYNE 2500SERIES; VOLUMETRIC EXERCISER (SPIROMETER THERAPEUTIC INCENTIVE)

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Congestive Heart Failure (1783); Death (1802); Pleural Effusion (2010); Pneumonia (2011); Injury (2348)

Event Date 08/20/2017

Event Type  Death  

Event Description

Caller reported that the device was used on her father to treat fluid in the lungs with crackles and possibly led to his death.Her father had anemia, possible congestive heart failure, acute kidney injury, possible pneumonia and was not on antibiotics.Pt had been treated with digoxin and aspirin prior device use.Caller is questioning if it is safe to use this device on a pt with these diagnosis and who is on oxygen.She does not want this to happen to another person.

• Brand Name: HUDSON-RCI VOLDYNE 2500SERIES
• Type of Device: VOLUMETRIC EXERCISER (SPIROMETER THERAPEUTIC INCENTIVE)
• Manufacturer (Section D): TELEFLEX MEDICAL ; 2917 weck dr; NC 27709
• MDR Report Key: 7689356
• MDR Text Key: 114076081
• Report Number: MW5078409
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 88 YR
• Patient Weight: 86