MAUDE Adverse Event Report: CAREFUSION SD ALARIS SPO2- NELLCOR; OXIMETER

Model Number 8220

Device Problems Break (1069); Crack (1135); Mechanics Altered (2984); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

The affected device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

It was reported that the device dome light was broken.No additional information was provided.There was no patient involvement.

Manufacturer Narrative

This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they replaced broken status indicator lens, front case, shielded rear case, keypad and 3rd party left/right iui(inter-unit-interfac).Based on the findings, service determined that the reported issue was due to customer damage of the front case.Device history record a review of the device history record showed the device had a manufacture date of 06aug2012.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record for sn (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record was performed for the sn (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.

Event Description

It was reported that the device dome light was broken.No additional information was provided.There was no patient involvement.

Event Description

It was reported, that the device dome light was broken.No additional information was provided.There was no patient involvement.

Manufacturer Narrative

This device was evaluated and repaired through the service repair process.Upon visual inspection, the service technician noted, that they replaced broken status indicator lens and front case, replaced shielded rear case with unshielded rear case, replaced lifted keypad, replaced 3rd party left iui and right iui.The failure code othe was used to track the alaris pump software version as received from the customer, and the software version when device was sent back to the customer.It does not reflect a device failure or represent any risk to the patient.Bd does not condone the use on non-supported parts within any of the alaris system devices.The risk of non-supported parts installed in the device(s) by the customer is unknown.A review of the device history record showed, the device had a manufacture date of 06aug2012.The review was performed, from the date of manufacture to the date of product release for distribution.A review of the device history record in sap for sn#: (b)(6) was performed.Which confirmed, that this device was not involved in a production failure.Which correlates to the customer reported issue.Based on the findings, service determined, that the probable root cause of the reported issue was, due to customer damage of the front case, damaged/ cracked (broken status indicator lens).A review of the complaint history record in trackwise and sap was performed, for the sn#: (b)(6).Which did not confirm, similar complaints with the same or related failure mode for this customer.

• Brand Name: ALARIS SPO2- NELLCOR
• Type of Device: OXIMETER
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11611927
• MDR Text Key: 243703563
• Report Number: 2016493-2021-502022
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10885403822018
• UDI-Public: 10885403822018
• Combination Product (y/n): N
• PMA/PMN Number: K022677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8220
• Device Catalogue Number: 8220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2721-2020
• Patient Sequence Number: 1