MAUDE Adverse Event Report: AMBU A/S SPUR II ADULT RESUSCITATOR; SPUR II RESUSCITATOR

Catalog Number 523611030

Device Problem Deflation Problem (1149)

Patient Problem Dyspnea (1816)

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

The affected resuscitator was not received for investigation,neither was a picture provided.Lot no.Was not provided and investigation could therefore not be made on retention sample, neither could production records be review.Contacted customer several times to obtain more information about the incident, customer is not responding.Due to limited information, it is difficult to verify the reported failure and the root cause of the reported failure cannot be identified.Customer has stated that patient condition was affected, but we has not been possible to obtain information on how patient was affected.Spur ii resuscitator is designed for use by cpr-trained paramedics, and information for safety provided in accompanying document (ifu) inform that the resuscitator must be unpacked and prepared for immediate use before it is placed ready for use in emergency situation.The integrity of kits issued for storage ready for use should be inspected at regular intervals.Caution has been given to alert the user to switch to mouth-to-mouth resuscitation if efficient ventilation cannot be obtain with the device.It is evaluated, that if the user had adhered to the instructions provided the device would not have been assumed to be ready for use.

Event Description

The mask is deflated and according to customer the exhalation valve is not on the bag, staff had to leave the bedside to find equipment to replace the masks.Delay of patient care.Patient was trauma patient with oxygen need.

• Brand Name: SPUR II ADULT RESUSCITATOR
• Type of Device: SPUR II RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, DK 27 50; DA DK 2750
• Manufacturer (Section G): AMBU A/S; 6230 old dobbin lane; suie 250; columbia MD 21045
• Manufacturer Contact: sanjay parikh ; 6230 old dobbin lane; suite 250; columbia, MD 21045 ; 4107686464
• MDR Report Key: 6588117
• MDR Text Key: 76036887
• Report Number: 9610691-2017-00003
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 523611030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/26/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 50 YR
• Patient Weight: 75