MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC MEDIC RESPONDER VENT; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	120002V
Medical Device Problem Codes	Free or Unrestricted Flow (2945); Device Difficult to Maintain (3134)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the oxygen free flows when plugged into oxygen.Preventative maintenance (pm) needed.Patient involvement unknown.
Additional Manufacturer Narrative
B3: date of event and d4: udi number is 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 additional reportable information becomes available.
Additional Manufacturer Narrative
Other, other text: additional information is provided for h.2, h.3, and h.6.One device was received for evaluation.Visual inspection revealed the device air mix switch cam assembly was damaged.Functional testing was performed, and the reported issue was unable to be replicated.However, on closer inspection, the air mix switch cam assembly has been subjected to impact force.The root cause could not be determined.Product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a dhr review was not performed.The service history review found the previous service replaced the oscillator which is related to the 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).
Additional Manufacturer Narrative
D4: udi updated **udi related data quality updates only**.

• Brand Name: PNEUPAC MEDIC RESPONDER VENT
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 17971750
• Report Number: 3012307300-2023-09782
• Device Sequence Number: 7044380
• Product Code: BTL
• UDI-Device Identifier: 10610586045479
• UDI-Public: (01)10610586045479(11)121001
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K020899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2024

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: Health Professional
• Device Catalogue Number: 120002V
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 03/18/2024; Not provided
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 07/01/2024; 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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