MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PNEUPAC PARAPAC PLUS 310, STAGE 3 BOXING; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	530A1167
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Component (2292); Battery Problem (2885); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 the device had inaccurate readings, a defective manometer, internal leakage, and a depleted battery.The product is available for repair.This was discovered prior to patient use and there was no patient harm.The reported product fault occurred during testing and no medical intervention was required.
Additional Manufacturer Narrative
D9: date returned to mfg.: unknown.H3 and h6.Codes: updated.Device evaluation: it was found that the returned device leaked due to disconnection at gas supply.Long continues flow at a very low bpm for normal operating mode.The device also had a faulty functional switch module, frequency module, vrv, and required a new patient valve.The device failed performance tests including lock off leak test, peep performance test, relief valve test, o2 therapy / cpap output control test, and frequency and tidal volume test.The unit was beyond economic repair.Customer requests to return the device unrepaired.

• Brand Name: PNEUPAC PARAPAC PLUS 310, STAGE 3 BOXING
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; bramingham business park; enterprise way; luton, bedfordshire MN LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19840391
• Report Number: 3012307300-2024-06701
• Device Sequence Number: 15395944
• Product Code: BTL
• UDI-Device Identifier: 35019315107478
• UDI-Public: (01)35019315107478(11)171002
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: 530A1167
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2017
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown