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

Model Number	530A1167
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pressure needle was broken.Patient involvement is unknown.
Additional Manufacturer Narrative
Date of event is unknown, no information has been provided to date.Device evaluation: one device was returned for investigation.Visual inspection noted: "device was received in with damages on the instruction label, front panel label and battery cover, surrounding the patient outlet connector, eye ball with glue, scratches on manometer glass, tidal volume is rubbing to front panel." the tamper seal was damaged.Functional testing was able to duplicate and confirm the reported complaint.Root cause was attributed to the damaged front panel."tidal volume was rubbing to damaged front panel." the service history review identified there was no indication that the complaint was related to a service of the device within the review period.Changed rfv assembly.

• Brand Name: PNEUPAC PARAPAC PLUS 310, STAGE 3 BOXING, SPAIN
• 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: 19072570
• Report Number: 3012307300-2024-02300
• Device Sequence Number: 14616940
• Product Code: BTL
• UDI-Device Identifier: 35019315107478
• UDI-Public: (01)35019315107478(11)140515
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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: 530A1167
• Device Catalogue Number: 530A1167NES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2014
• 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