MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PNEUPAC PARAPAC VENTILATOR W/ ALARMS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	P200DNUS
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: 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 product's low-pressure alarm kept sounding even though it was in a demand state.There was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Device evaluation: one device was returned for investigation.Visual inspection found the front panel of the main body case was bent.It was also confirmed that the hinge of the transplant switch cover was deformed.The power switch is out of position, and the low circuit internal pressure alarm sounds when the demand setting is set.The complaint was confirmed.Root cause was presumed to be the impact caused by the main unit dropping, etc.The deformed front panel was repaired.Then, replacement of power switch and the transplant cover.The 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 VENTILATOR W/ ALARMS
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; enterprise way; luton LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18981653
• Report Number: 9611178-2024-00066
• Device Sequence Number: 20475710
• Product Code: BTL
• UDI-Device Identifier: 35019315072738
• UDI-Public: (01)35019315072738(11)170222
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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: P200DNUS
• Device Catalogue Number: P200D/NJJP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2017
• 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