MAUDE Adverse Event Report: HELENA LU MAQUET; TUBING, PRESSURE AND ACCESSORIES

Device Problem Detachment Of Device Component (1104)

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

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).The investigation has been done together with maquet service us as following.The end beam cover was cracked and fell off after being hit by other equipment in the room, rather than a normal use.This event occurred during the clean process by the night cleaning crew of hospital, and no patient was in the room at that time.As checked, this unit was manufactured and delivered in year 2015, and there was no any feedback regarding the end beam cover connection during installation or previous maintenance.Therefore, we could believe it¿s in a normal condition as intended the design of the end beam cover is demonstrated compliance with (b)(4) by design verification, and additionally a warning is included in user manual to remind the customer to avoid collision when moving devices.Therefore, the design of the end beam cover was demonstrated robust for normal use.With the above information, we can indicate this complaint case is caused by use error- careless during positioning of the device which resulting in the hitting between devices.Maquet service us had replaced the damaged end beam cover and reminded the hospital staff to take care when positioning the device.

Event Description

On (b)(6) 2017, the hospital staff told maquet service us that the beam end cover of the modutec fell off after being hit.No injury was reported.(b)(4).

• Brand Name: MAQUET
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): HELENA LU; maquet (suzhou) co., ltd; no.158, fang zhou rd. suzhou; suzhou 21502 4; CH 215024
• Manufacturer (Section G): HELENA LU; maquet (suzhou) co., ltd; no.158, fang zhou rd. suzhou; suzhou 21502 4; CH 215024
• Manufacturer Contact: maquet (suzhou) co., ltd; no.158, fang zhou rd. suzhou; suzhou 21502-4
• MDR Report Key: 6861127
• MDR Text Key: 86300417
• Report Number: 3007417753-2017-00006
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1