MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. COACH 2 INCENTIVE SPIROMETER; SPIROMETER, THERAPEUTIC (INCENTIVE)

Model Number 22-500

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

Patient Problem Pneumonia (2011)

Event Type  Injury  

Event Description

A report was received from a homecare user alleging that following use of the listed incentive spirometer, the user contracted pneumonia.The user stated that they were unsure how or when to clean the device due to alleged deficiencies in the instructions for use.No permanent adverse effects to patient reported.The end user refused to identify themselves and wanted to remain anonymous, therefore, no information is available for initial reporter or user facility.

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

• Brand Name: COACH 2 INCENTIVE SPIROMETER
• Type of Device: SPIROMETER, THERAPEUTIC (INCENTIVE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; rockland MA
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 160 weymouth st.; rockland MA 02370
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4336278
• MDR Text Key: 5143038
• Report Number: 2183502-2014-00933
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• PMA/PMN Number: K970596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 22-500
• Device Catalogue Number: 22-500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2014
• Event Location: Home
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other