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

Catalog Number	530A1167
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event 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.
Event or Problem Description
It was reported that the device operators reported an oxygen leak for this device.The reporter checked the device and there appears to be no leak externally and the device operates as it should.However, when the oxygen hose is connected to the oxygen tank and the switch is set to "off", there is a hissing noise coming from inside the device.Michael carrick from barts health nhs trust, reported on behalf of the royal london hospital.They are unsure of the event's date.There was no patient harm and no medical intervention.The issue was found before use with a pre use check.
Additional Manufacturer Narrative
H6: evaluation codes updated device evaluation: one device was received.A visual inspection found the device was received with a damaged tamper seal.During the functional testing, the peep, cpap and o2 concentration (50%) over limits and there was inside leakage.The customer reported problem was confirmed.The cause of the issue was the o2 leakage.No action was taken as the device will be scrapped.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: PNEUPAC PARAPAC PLUS, 310, STAGE 3 BOXING
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19264972
• Report Number: 3012307300-2024-03475
• Device Sequence Number: 6981548
• Product Code: BTL
• UDI-Device Identifier: 35019315107478
• UDI-Public: (01)35019315107478(11)111115
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2024

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: 530A1167
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2015
• 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