MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC PARAPAC MEDIC MODEL; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	120003
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.H3: other; device 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 was damaged face plate and knobs.The nurse reported desaturation on patient.The delay of therapy was unknown and adverse patient effects are unknown.
Additional Manufacturer Narrative
One device was received for investigation.Device was received in with a bowed front panel on the left side of the manometer and missing o2/relief knobs.Based off the visual inspection the reported complaint is confirmed.The root cause is impact to the device.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• Brand Name: PNEUPAC PARAPAC MEDIC MODEL
• 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: 19112177
• Report Number: 3012307300-2024-02584
• Device Sequence Number: 15258012
• Product Code: BTL
• UDI-Device Identifier: 10610586045486
• UDI-Public: 10610586045486
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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: 120003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2010
• 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