MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-S; VENTILATOR, CONTINUOUS, FACILITY USE

Catalog Number 6640440

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the ventilator experienced power failure.There was no patient involvement.(b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of maquet critical care ab (manufacturer).Ref.Exemption #:(b)(4).Getinge usa sales, llc (b)(4).Contact peron: (b)(6).The investigation regarding the reported complaint has been finalized.The unit was investigated by our field service engineer (fse).The investigation concluded that the panel led indicator was not light.The dc/dc pc(printed circuit) board was replaced and returned for investigation.The visual inspection of the replaced and returned dc/dc board revealed a physical damage.Two of the pins on the panel connector had been broken off and were missing.The power to the panel comes via the device dc/dc board.Our review of the device logs confirms the same failure, alarms regarding user interface communication error, and on/off switch error can be verified.The failure is a communication failure to the device panel only, it will not affect ongoing ventilation.If the failure is detected by system start-up, the screen will not light up and ventilation cannot be started.The conclusion is that the device was used outside it's expected usage, in relation to the broken/missing pins.

Event Description

Manufacturer ref.#: (b)(4).

• Brand Name: SERVO-S
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 8119514
• MDR Text Key: 129154394
• Report Number: 8010042-2018-00644
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6640440
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 11/30/2018
• Supplement Dates Manufacturer Received: 11/12/2018
• Supplement Dates FDA Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1