MAUDE Adverse Event Report: TELEFLEX MEDICAL VOLDYNE2500 VOLUMETRIC EXERCISER; SPIROMETER, THERAPEUTIC (INCEN

Catalog Number 8884719025

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 08/20/2017

Event Type  Death  

Manufacturer Narrative

Qn# (b)(4).The sales rep spoke with the patient's daughter and she relayed to the sales rep that her father passed away in the hospital "from pneumonia, dehydration, and anemia and lack of care but felt using the voldyne as he was instructed by nursing put him into cardiac arrest." the patient's daughter reports that the device was taken to the hospital when the patient returned and is not available for investigation.Complaint verification testing could not be performed as no sample was returned for analysis.The ifu for this product states "frequency of use and recommended inspiratory volumes should be performed at the direction of your physician." without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint was reported as: "[name removed] called in regarding the death of her father [name removed].Patient was (b)(6) years old with heartburn, shoulder pain, anemia, conjunctive heart failure, and was weak.[name removed] stated that the patient was given item# 8884719025 before the iv was stopped and believes the device was given in error for several reasons.She mentioned that the label says to stop use at 80ys and patient was (b)(6).She also said that the options given to the patient were to either use the incentive spirometer or be sent home with an oxygen tank, which he did not want.After use, he developed leg cramps and excessive shaking." customer also reports: "patient was on 3l of oxygen at hospital.Oxygen level dropped to 76 and [name removed] believes that the product counteracts the benefits of supplemental oxygen and is what caused the patient to hyperventilate, suffer a stroke and severe anoxia.".

• Brand Name: VOLDYNE2500 VOLUMETRIC EXERCISER
• Type of Device: SPIROMETER, THERAPEUTIC (INCEN
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 8767522
• MDR Text Key: 150282460
• Report Number: 3003898360-2019-00752
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 8884719025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death
• Patient Age: 88 YR