MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) CARTO 3 EXTERNAL REFERENCE PATCH; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number D-1283-02

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(4).

Event Description

It was reported that an employee slipped and fell as a result of stepping on a disposable clear plastic sheet from the c3 external reference patch that was on the floor.It was noted that due to the clear nature of the material, it was not visible.Since this adverse event might result in permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 1/23/2017.The carto 3 external reference patch film has markings similar to the traction sole of a shoe or a boot.The left corner was slightly bent.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that an employee slipped and fell as a result of stepping on a disposable clear plastic sheet from the c3 external reference patch that was on the floor.It was noted that due to the clear nature of the material, it was not visible.Upon visual inspection it was noticed that the clear film had several foot print marks on it, no patches were attached to the film.The device's design has been in the market for years.No malfunction found on device.Issue will be communicated to supply quality; however, there is no resolution at this time as there is no product fault found.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.

• Brand Name: CARTO 3 EXTERNAL REFERENCE PATCH
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6123456
• MDR Text Key: 60749977
• Report Number: 2029046-2016-00249
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1283-02
• Device Catalogue Number: CREFP6
• Device Lot Number: UNKNOWN_D-1283-02 (DO NOT USE)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other