MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC PARAPAC PLUS, JAPANESE PANEL; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	P300NJ
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: b3: month and year of event have been provided, day is unknown.D4: udi number is unknown; no information has been provided to date.G5: 510k is blank, this catalog number is not sold in the united states.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 that during the maintenance check up, gso engineer noticed the outlet was tightened with the torque of 4.5n or smaller.No patient involvement.
Additional Manufacturer Narrative
Other, other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.One device was received.Per visual inspection, there was no abnormality in the appearance of the main body.Per functional testing, checked for looseness of the patient outlet connector.The complaint was confirmed.The root cause was because the load in the loosening direction is applied when the patient circuit is attached or detached attributed to the product design.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Tighten the patient circuit connector with a force of 4.5 nm.The device passed all functional and delivery tests.
Additional Manufacturer Narrative
D4: udi updated.Udi related data quality updates only.

• Brand Name: PNEUPAC PARAPAC PLUS, JAPANESE PANEL
• 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: 18095199
• Report Number: 3012307300-2023-10339
• Device Sequence Number: 20514740
• Product Code: BTL
• UDI-Device Identifier: 35019315107270
• UDI-Public: (01)35019315107270(11)211118
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2024

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 Model Number: P300NJ
• Device Catalogue Number: P300NJJP
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/20/2023
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: 11/07/2023; Not provided
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 01/17/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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