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

Model Number 530A1167

Device Problems Device Alarm System (1012); Failure to Cycle (1142); Gas Output Problem (1266); No Device Output (1435)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/26/2023

Event Type  Injury  

Event Description

It was reported that during patient use the ventilator suddenly beeped with alarm sounds.Users found that the ventilator manometer pointed to zero and the indicator was not moving.At the same time the patients spo2 dropped from 97 percent to 89 percent and the heart rate (hr) increased from 84/min to 97/min.The nurse immediately checked that both the oxygen hose and the breathing circuit were connected without bends and no air leakage sound was heard.The nurse then connected the oxygen hose to the fx oxygen cylinder but the indicator of the ventilator manometer still pointed to zero without movements.The icu doctor immediately used a bag valve mask to assist the patient in breathing.The patients spo2 returned to 100 percent with an hr of 90/min.The patient was safely sent back to the icu with vital signs similar to before and spo2 remained at percent.No patient injury.

Manufacturer Narrative

Other text: d4: udi number 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.

Manufacturer Narrative

Other text: d4: udi updated - (b)(4).H6: evaluation codes updated, device evaluation: one device was received.A visual inspection found the device in a good physical condition.The tidal volume knob was not on min x max position.During the functional testing, the device failed the tests.The customer reported problem was not duplicated but other issues were found.The cpap and peep needed to be adjusted, and rfv will be replaced.Product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a dhr review was not performed.There was no indication of a service issue during the investigation.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

Manufacturer Narrative

Udi related data quality updates only.

• Brand Name: PNEUPAC PARAPAC PLUS STAGE 3 BOXING
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18194699
• MDR Text Key: 328828061
• Report Number: 3012307300-2023-10768
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K123957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 530A1167
• Device Catalogue Number: 530A1167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 02/09/2024; Not provided
• Supplement Dates FDA Received: 06/26/2024; 07/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention