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

Catalog Number P200D/NJJP

Device Problem False Alarm (1013)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date of event 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 Description

It was reported that there are unusual things happening.The device was alarming when the power is turned on.Patient involvement is unknown.

Manufacturer Narrative

Additional information: e1 postal code.H3 and h6 - evaluation codes: updated.Device evaluation: one device was returned for investigation.No abnormalities in the appearance of the product related to the reported event could be confirmed.Functional testing confirmed that the electronic alarm would not sound.Root cause was attributed to a defective interface printed circuit board.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.Replacement of interface pcboard.Device passed the functional and performance tests after the repair.

• Brand Name: PNEUPAC PARAPAC WITH ALARMS
• Type of Device: 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: 18557453
• MDR Text Key: 333469437
• Report Number: 9611178-2024-00024
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: P200D/NJJP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/28/2023
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1