MAUDE Adverse Event Report: CAREFUSION SENSORMEDICS

Model Number 3100B

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2014

Event Type  malfunction  

Event Description

The following description of the event was documented by a carefusion technical support specialist in response to a phone conversation with a user facility rep."(name removed) put in an 8k kit pm (b)(4) on this unit under order number (b)(4).He was doing the alarm function check out when he checks the thumbwheels and noticed the max thumbwheel is not functioning.He said that on tp3 on the alarm board it just reads 14 volts all the time and it won't alarm.It should not be reading that high, the max voltage should be 2.95 volts.He has the map set to 39 cm and the max thumbwheel is set to 11 cm and it won't alarm.No pt involvement.He is doing the 8k pm on this unit.We swapped the thumbwheel out with the old one and it is working fine.I will sent him a replacement thumbwheel pn (b)(4) as he has already put all the parts from the 8k in the unit etc.(b)(4) is the order for the replacement thumbwheel and is also the rga # for the defective one to come back under." "(name removed) reported he found an issue with the solder on the thumbswitch.He will sent the defective one back.".

Manufacturer Narrative

The user facility did not submit a user facility report to the mfr.Codes were derived based on the info documented by a carefusion technical support specialist in response to a phone conversation with a user facility rep.(b)(4).The carefusion tech support specialist in conjunction with the user facility's biomed determined that the most likely cause of the reported event was a faulty thumbwheel switch received as a part of the 8,000 hour preventive maintenance (pm) kit for the device.The user facility was shipped a replacement thumbwheel switch to repair the device and return it to service.Carefusion issued a return goods authorization (rga) number to the user facility for the return of the alleged faulty thumbwheel switch for eval.As of december 29 2014 the alleged faulty thumbwheel switch has not been received.Should the alleged faulty thumbwheel switch be received and evaluated, a follow up medwatch report will be submitted.

• Brand Name: SENSORMEDICS
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: james stytle ; 1100 bird center dr.; palm springs, CA 92262 ; 7608837120
• MDR Report Key: 4386847
• MDR Text Key: 5362856
• Report Number: 2021710-2014-00139
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100B
• Device Catalogue Number: 770155
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/03/2014
• Device Age: 7 YR
• Event Location: Hospital
• Date Manufacturer Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1