MAUDE Adverse Event Report: RESMED LTD APNEALINK BASIC SET US; VENTILATORY EFFORT RECORDER

Model Number 22302

Device Problems Burst Container or Vessel (1074); Battery Problem (2885)

Patient Problem Burn(s) (1757)

Event Date 04/20/2015

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer, therefore, resmed is unable to determine at this time if the incident was caused by the alleged malfunction.Resmed is in communication with the reporter to obtain additional information regarding event details and has requested the unit be returned so that an extensive engineering investigation can be performed.Once the device is returned and the investigation is completed, resmed will provide a follow-up report with additional information.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that an apnealink home sleep testing device allegedly malfunctioned causing first degree burns to the user's abdomen.

Manufacturer Narrative

The device was not returned to resmed for investigation.Pictures of the device and patient burns were provided to resmed, therefore, the complaint could be confirmed.An extensive engineering investigation was performed on the pictures.Review of the pictures provided to resmed revealed that the device was used with batteries with greater voltage than specified in the resmed clinical manual.Based on the information available, the investigation determined that the reported event was most likely due a short circuit of the batteries used with the device.The apnealink device does not contain a built in power source.Power requirements are defined in the clinical manual.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Note: during an audit of the complaint records, it was found that a follow-up report is required as new information is available.This report is submitted to address the reportable event.Resmed reference#: (b)(4).

• Brand Name: APNEALINK BASIC SET US
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista, nsw 2153 ; AS 2153
• Manufacturer Contact: david duley ; 9001 spectrum center blvd; san diego, CA 92123 ; 8588365985
• MDR Report Key: 5283294
• MDR Text Key: 33097844
• Report Number: 3004604967-2015-00691
• Device Sequence Number: 1
• Product Code: MNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 22302
• Device Catalogue Number: 22302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/23/2016
• Device Age: 8 YR
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Weight: 118