MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX PNEUPAC VENTILATOR SUPPORT GAUGE; METER, AIRWAY, PRESSURE (INSPIRATORY FORCE)

Model Number	55-6060
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Zero (1683)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the gauge does not read correctly and is not set for zero (0).Patient involvement is unknown.
Additional Manufacturer Narrative
Other, other text: b3: date of event, d4: lot number, expiration date, and h4: manufacture date are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Additional Manufacturer Narrative
A sample was received for evaluation.The sample was visually evaluated, and event was confirmed that the black indicator needle on the gauge reads -7.5 cmh20.Per our manufacturing procedures the operator is supposed to 100% visually inspect the gauge reads zero with 100%-inspect confirmation of functionality.The instructions for use for the product state the user is allowed to take the faceplate off and move the gauge to "0" (zero) with a screwdriver.The returned product was tested for functionality and accuracy using a pressure and vacuum test.The faceplate was removed, the gauge moved to 0, and then tested.The product met specifications; therefore, this defect cannot be confirmed.The root cause is assembly error.The product's history records were reviewed and there were no non-conformances that would have resulted in the reported complaint.For all enquiries or follow-up questions related to the record, do not use (b)(6).Located in sections g.1., please direct those to the following: (b)(6).

• Brand Name: PORTEX PNEUPAC VENTILATOR SUPPORT GAUGE
• Common Device Name: METER, AIRWAY, PRESSURE (INSPIRATORY FORCE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16827964
• Report Number: 3012307300-2023-04686
• Device Sequence Number: 7131786
• Product Code: BXR
• UDI-Device Identifier: 10788942560604
• UDI-Public: 10788942560604
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K873498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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: Other
• Device Model Number: 55-6060
• Device Catalogue Number: 55-6060
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown