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

Model Number	27-9001
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluation in progress.
Event or Problem Description
It was reported that portex acapella failed to vibrate.This product problem was observed immediately upon use.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
The initial report with mfr number 3012307300-2020-12137 was erroneously sent as malfunction report.Secondary review determined that the event was not malfunction reportable.This is therefore a redaction report.H1: type of reportable event: although this field is currently populated with the entry of malfunction for the purposes of the report, it should be noted that this actually a redaction report.The incident that was previously reported on, involved a product problem that was not malfunction reportable.In addition, no adverse events were reported in connection with the previously reported incident.
Event or Problem Description
Redaction report.Please see h10 for details.

• Brand Name: PORTEX ACAPELLA
• Common Device Name: SPIROMETER, THERAPEUTIC (INCENTIVE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• MDR Report Key: 10950933
• Report Number: 3012307300-2020-12137
• Device Sequence Number: 4330121
• Product Code: BWF
• UDI-Device Identifier: 10788942290013
• UDI-Public: 10788942290013
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K002768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/18/2022
• Device Model Number: 27-9001
• Device Catalogue Number: 27-9001
• Device Lot Number: 3495360
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1