MAUDE Adverse Event Report: MR730 RESPIRATORY HUMIDIFIER

Model Number MR730

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Low Oxygen Saturation (2477)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).We are in the process of obtaining further information and the return of the subject mr730 respiratory humidifier for investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor in (b)(4) reported on behalf of a caregiver, via a fisher & paykel healthcare (f&p) field representative, that a patient using a mr730 respiratory humidifier developed a mucous plug and desaturated.The caregiver performed lavage and suction, noting that the patient's trachea was dry.It was further reported that the patient was transferred to a mr850 respiratory humidifier with a philips trilogy ventilator and recovered to 95% oxygen saturation.It was reported that the mr730 respiratory humidifier did not appear to be malfunctioning as there were no error codes or alarms.There were no further patient consequences.

Manufacturer Narrative

(b)(4).Method: the complaint mr730 respiratory humidifier was requested but not returned to fisher & paykel healthcare (f&p) for evaluation.Further information was requested from the customer, however no further information was received.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer reported that a patient using a mr730 respiratory humidifier developed a mucous plug and desaturated.It was further reported that the mr730 respiratory humidifier did not appear to be malfunctioning as there were no error codes or alarms.Conclusion: without the complaint device, we are unable to determine what caused the reported event.Based on the information provided by the customer, there was no fault with the subject device.The mr730 respiratory humidifier is used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance via an endotracheal tube or face mask.The warmth and moisture are supplied by passing the gas over heated water and the temperature of the gas flowing through the breathing circuit can be maintained by a heater wire.Temperature is controlled accurately and measured via temperature probes located at the patient end of the delivery tube and at the humidification chamber outlet.The mr730 respiratory humidifiers meet all the relevant standards for safety and performance including iec60601-1 (the international electrotechnical commission requirements for medical electrical equipment) and derivatives, which covers electrical safety for medical devices.

Event Description

A distributor in maryland reported on behalf of a caregiver, via a fisher & paykel healthcare (f&p) field representative, that a patient using a mr730 respiratory humidifier developed a mucous plug and desaturated.The caregiver performed lavage and suction, noting that the patient's trachea was dry.It was further reported that the patient was transferred to a mr850 respiratory humidifier with a philips trilogy ventilator and recovered to 95% oxygen saturation.It was reported that the mr730 respiratory humidifier did not appear to be malfunctioning as there were no error codes or alarms.There were no further patient consequences.

• Brand Name: MR730 RESPIRATORY HUMIDIFIER
• Type of Device: MR730 RESPIRATORY HUMIDIFIER
• MDR Report Key: 11735599
• MDR Text Key: 247670791
• Report Number: 9611451-2021-00494
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K913368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MR730
• Device Catalogue Number: MR730
• Device Lot Number: 030923
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2003
• 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
• Treatment: VOCSN BREATHING CIRCUIT.; VOCSN BREATHING CIRCUIT.; VOCSN VENTILATOR.; VOCSN VENTILATOR.; VOCSN BREATHING CIRCUIT; VOCSN VENTILATOR
• Patient Outcome(s): Required Intervention