MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER; VENTILATOR, EMERGENCY, MANUAL

Model Number IPN914089

Device Problems Disconnection (1171); Incomplete or Inadequate Connection (4037)

Patient Problem Death (1802)

Event Date 10/08/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).A physician at the user facility reported the death of the patient is not linked with the issues faced with the device.It was reported the patient was in cardiac arrest prior to use of the device.

Event Description

The complaint is reported as: "during a resuscitation intervention following a vascular cardiac arrest on (b)(6) 2020, the connection/tubing between device and the mobile oxygen cylinder could not be done correctly and the movements of the tubing caused disconnections.The consequences: delay increased for the intervention and disrupted resuscitation.The female patient died." it was reported "the device was not involved in the death, as the patient could not have been resuscitated anyway.".It was also reported "this issue delayed the start of resuscitation and needed staff to provide the oxygen supply.".

Event Description

The complaint is reported as: "during a resuscitation intervention following a vascular cardiac arrest on (b)(6) 2020, the connection/tubing between device and the mobile oxygen cylinder could not be done correctly and the movements of the tubing caused disconnections.The consequences: delay increased for the intervention and disrupted resuscitation.The female patient died." it was reported "the device was not involved in the death, as the patient could not have been resuscitated.It was also reported "this issue delayed the start of resuscitation and needed staff to provide the oxygen supply''.

Manufacturer Narrative

(b)(4).The sample was returned and sent to the manufacturer (galemed) for investigation.Galemed reports a visual exam was performed and it was observed that a connector at one end of the oxygen tube to connect the device was missing.Due to the lack of connector, the inner diameter size of the connector could not be measured.The manufacturing and inspection records of (b)(4), (hd-45372, lot no 90826) were reviewed, and no issues related to the reported complaint were found.It was also reported "in the past 5 years, the complaint records have been reviewed, we have not received similar complaints before, so we considered that it was a single case.".

• Brand Name: HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER
• Type of Device: VENTILATOR, EMERGENCY, MANUAL
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10803472
• MDR Text Key: 215116058
• Report Number: 3011137372-2020-00241
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• PMA/PMN Number: K964719
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN914089
• Device Catalogue Number: 45372
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Death