MAUDE Adverse Event Report: AESCULAP, INC. AIR HOSE 3.0M AES.-DRAEGER/AESC.SMALL

Model Number GA513R

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2015

Event Type  malfunction  

Manufacturer Narrative

Us reporting agent notified on: (b)(6) 2015.Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).Air hose failed during use in operating room.Attending nurse took 6 days of sick leave as a result; and had to be treated y the otorhinolaryngologist due to loss of hearing.The attending physician was also out on sick leave the day after the incident.

• Brand Name: AIR HOSE 3.0M AES.-DRAEGER/AESC.SMALL
• Manufacturer (Section D): AESCULAP, INC.; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): AESCULAP, INC.; po box 40; tuttlingen 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe dr.; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5032866
• MDR Text Key: 24245833
• Report Number: 2916714-2015-00729
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA513R
• Device Catalogue Number: GA513R
• Date Manufacturer Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1