MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. STAGE 3 BOXING PNEUPAC PARAPAC PLUS 310 POLAND; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number 530A1167

Device Problem Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that the problem was "in peep pressure (max 12 cmh2o)".Patient involvement is unknown.

Manufacturer Narrative

B3: date of event and d5: operator of device are unknown; no information has been provided to date.(b)(6).Device evaluation: visual inspection found the device was received in good condition.Tamper seal was undamaged.Device passed functional testing.The complaint could not be duplicated or confirmed.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.Device will be serviced.No further action will be taken.

• Brand Name: STAGE 3 BOXING PNEUPAC PARAPAC PLUS 310 POLAND
• 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: 18652013
• MDR Text Key: 334679242
• Report Number: 9611178-2024-00043
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K123957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2024

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
• Device Operator: Other
• Device Model Number: 530A1167
• Device Catalogue Number: 530A1167NPL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2019
• 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