MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON RCI FOLDABLE MANUAL RESUSCITATION BAG; MASK, OXYGEN

Catalog Number 5387

Device Problem Inflation Problem (1310)

Patient Problem Bradycardia (1751)

Event Date 07/21/2015

Event Type  malfunction  

Event Description

The patient underwent an upper endoscopy.When scope was removed in preparation for insertion of an ultrasound probe, the patient became unresponsive with oxygen saturation at 25%.A manual resuscitator was employed to ventilate the patient but the mask was found to have a deflated air cushion.Two additional manual resuscitators were quickly obtained but were also deflated.A resuscitator with an intact air cushion was located and the patient was successfully ventilated.The patient had developed bradycardia (to 30s) - likely secondary to hypercarbia/ hypoxia.This resolved with one dose of epinephrine.The patient was then alert, comfortable and neurologically intact.12-lead ekg was unchanged.A decision was made to cancel the exam.Manufacturer response for manual resuscitator, resuscitation bag foldable adult (per site reporter): the teleflex rep initially advised that since the masks have no expiration date perhaps the hospital should consider replacing unused resuscitators every 6 months.One month later he informed the hospital that the resuscitators actually expire 3 yrs from the date of manufacture and that this date can be determined from the 4 digit lot number - the first 2 digits indicate the year the product was made and the last 2 numbers indicate the week the product was manufactured.

• Brand Name: HUDSON RCI FOLDABLE MANUAL RESUSCITATION BAG
• Type of Device: MASK, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; 2917 weck dr.; research triangle park NC 27709
• MDR Report Key: 5159018
• MDR Text Key: 28582945
• Report Number: 5159018
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/22/2015

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: No Information
• Device Catalogue Number: 5387
• Device Lot Number: 1033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2015
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/22/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 109