MAUDE Adverse Event Report: SDI DIAGNOSTICS, INC. SPIROLAB II; SPIROMETER

Device Problems Unable to Obtain Readings (1516); Defective Component (2292); Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The machine would not register when the patient blew into the turbine.Unable to get results when attempting testing on patient.Patient was transferred to sister facility where testing was completed.
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manufacturer response for spirometer, spirolab ii (per site reporter).
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the display, battery pack, main pcb connector, cable connector, cable cover and mouthpiece holder need to be replaced.

• Brand Name: SPIROLAB II
• Type of Device: SPIROMETER
• Manufacturer (Section D): SDI DIAGNOSTICS, INC.; 10 hampden dr.; south easton MA 02375
• MDR Report Key: 4187961
• MDR Text Key: 17274790
• Report Number: 4187961
• Device Sequence Number: 1
• Product Code: BZG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2014
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2014
• Patient Sequence Number: 1