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

Model Number	P200DNUS
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event, d4: serial number, udi number.D5.Operator of device, g5: 510k and h4: device manufacture date 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 issue is due to missing circuit connection.There was unknown patient involvement and unknown patient harm adverse event reported.
Additional Manufacturer Narrative
Additional information: d4 - model number, serial number, udi number, g5, and h4 - manufacture date.H3 and h6 - evaluation codes: updated.Device evaluation: one device was returned for investigation.It was confirmed by visual inspection that the outlet connector on the main unit was missing.It was also confirmed that there were cracks in the switch cover (japanese specifications) of the main unit.It is thought that the outlet connector has become loose due to long-term use of the parapac.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.Attached the outlet connector to the main body and replacement of cracked switch covers.E1 - phone number.

• Brand Name: PNEUPAC PARAPAC 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18735713
• Report Number: 9611178-2024-00055
• Device Sequence Number: 6276057
• Product Code: BTL
• UDI-Device Identifier: 35019315072738
• UDI-Public: (01)35019315072738(11)130314
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020899
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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: 01/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 03/03/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2013
• 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