MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. THERAPEP PEP THERAPY SYSTEM; SPIROMETER, THERAPEUTIC (INCENTIVE)

Catalog Number	20-0050
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; no information has been provided to date.H3: other; device not returned to manufacturer.Expiration date and manufacture date are unknown, invalid lot number provided by the customer investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported by the patient that "the machine has not been working, and her condition is critical.Unable to breathe without the machine and has shortness of breath".Additional adverse patient effects are unknown.
Additional Manufacturer Narrative
D3.Manufacturing plant address 1: (b)(6).D3.Manufacturing plant city: (b)(6).D3.Manufacturing plant state: (b)(6).D3.Zip code: (b)(6).D4.Serial #: (b)(6).D4.Primary udi number: (b)(4).Investigation summary: no product was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: THERAPEP PEP THERAPY SYSTEM
• Common Device Name: SPIROMETER, THERAPEUTIC (INCENTIVE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19355707
• Report Number: 3012307300-2024-03969
• Device Sequence Number: 7703149
• Product Code: BWF
• UDI-Device Identifier: 10788942200500
• UDI-Public: (01)10788942200500
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: Lay User/Patient
• Device Catalogue Number: 20-0050
• Device Lot Number: 5598839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown