MAUDE Adverse Event Report: RESMED LTD OBSOLETE VPAP IV EUR2

Model Number 26106

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not yet been returned, therefore resmed is unable to confirm the alleged malfunction at this time.(b)(4).Device not returned.

Event Description

It was reported to resmed that while attaching an oxygen connector to the vpap iv, the device powered down and displayed an error message ""system error, call service." this resulted in a patient to have an oxygen desaturation.The patient was given supplemental oxygen and placed on a back-up device with no complications.There was no patient injury reported as a result of this incident.

Manufacturer Narrative

The device was returned to resmed and an extensive engineering investigation was performed.Review of the device logs confirmed the occurrence of "power-on-reset" error messages in the device.In-house testing could not reproduce the reported device failure; the device performed to specifications.Visual inspection of the returned device found evidence of water ingress in the internal components.The investigation determined that the reported failure was most likely due to water contamination of the device.Resmed's risk analysis for these failure modes concludes that the risk is acceptable.From the user manual contraindications: "your s8 series ii is not a life-support device and may stop operating during power failure or certain fault conditions.It should not be used by patients who are dependent on continuous therapy.¿ (b)(4).

Event Description

It was reported to resmed that while attaching an oxygen connector to the vpap iv, the device powered down and displayed an error message "system error, call service." this resulted in a patient to have an oxygen desaturation.The patient was given supplemental oxygen and placed on a back-up device with no complications.There was no patient injury reported as a result of this incident.

• Brand Name: OBSOLETE VPAP IV EUR2
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney 2153 ; AU 2153
• Manufacturer (Section G): RESMED CORP; 9001 spectrum center blvd; san diego CA 92123
• Manufacturer Contact: david duley ; 9001 spectrum center blvd; san diego, CA 92123
• MDR Report Key: 6309228
• MDR Text Key: 67125697
• Report Number: 3004604967-2017-00149
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K080131
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

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: Lay User/Patient
• Device Model Number: 26106
• Device Catalogue Number: 26106
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/02/2017
• Device Age: 7 YR
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1