MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC PARAPAC PLUS; VENTILATOR, EMERGENCY, POWERED (RES)

Catalog Number P310NUS

Device Problem Failure to Cycle (1142)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date of event and d4: serial number are unknown.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 Description

It was stated that the device was not cycling properly.There was unknown patient involvement and unknown patient harm/adverse event reported.

Manufacturer Narrative

Additional information: d4: serial number and h4: manufacture date.H3 - other: device not returned for investigation.H6 - evaluation codes: updated.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.The most probable cause is a faulty input manifold assembly.The device would stay in a continuous flow manner.Therefore, draining o2.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.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: PNEUPAC PARAPAC PLUS
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RES)
• 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: 18547532
• MDR Text Key: 333286383
• Report Number: 3012307300-2024-00325
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 35019315107263
• UDI-Public: 35019315107263
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: P310NUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1