MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. ADULT HIGH CONCENTRATION REBREATHER , 7FT (2.1); MASK, OXYGEN, NON-REBREATHING

Model Number 3104-E

Device Problem Disconnection (1171)

Patient Problems Adult Respiratory Distress Syndrome (1696); Respiratory Distress (2045); Low Oxygen Saturation (2477)

Event Date 10/20/2014

Event Type  No Answer Provided  

Event Description

The patient was using the oxygen rebreather mask during ambulation and had been using it for a few days when the tubing that connects the oxygen source to the oxygen rebreather mask became disconnected.The disconnection of the tubing from the oxygen source to the rebreather mask the patient was using caused a rapid oxygen desaturation in the patient.The patient was required to manually reconnect the oxygen tubing to the rebreather mask.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury and reportable malfunction.No further information was available at the time of the report.A returned sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.

• Brand Name: ADULT HIGH CONCENTRATION REBREATHER , 7FT (2.1)
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon secc. 4; lote 7, parque ind. del norte; reynosa, tams. 8873 6; MX 88736
• Manufacturer Contact: matthew walenciak, int.assoc.dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4291317
• MDR Text Key: 21339790
• Report Number: 9680866-2014-00041
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2019
• Device Model Number: 3104-E
• Device Lot Number: 105838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 85