MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-I; SUPPORT, ARM

Model Number SERVO-I

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2021

Event Type  malfunction  

Manufacturer Narrative

No parts were returned.Investigation was based on picture received.According to the picture, the support arm broke at the joint second nearest to the bracket.The support arm is a casting and it most probably developed a crack at an earlier occasion either by overloading or impact and this led to the reported breaking.The support arm has been successfully tested for mechanical strength and is designed according to standard.Previous investigations of similar faults led to a redesign and change of the manufacturing process in order to obtain a higher mechanical strength of the support arm.The support arm associated with this complaint had been manufactured before this change was implemented in production.

Event Description

It was reported that the support arm broke at the lower end.Patient involvement is unknown.Manufacturer's ref #: (b)(4).

• Brand Name: SERVO-I
• Type of Device: SUPPORT, ARM
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 11876701
• MDR Text Key: 252398160
• Report Number: 8010042-2021-01176
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/25/2021

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 Model Number: SERVO-I
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1