MAUDE Adverse Event Report: SPIEGELBERG GMBH & CO. KG SPIEGELBERG ICP PROBE

Model Number	SND13.1.53
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distributor could not provide further information on device usage or patient outcome upon request.The returned device was evaluated by spiegelberg and showed liquid in the air lumen which leads to a connected icp monitor displaying an error code as claimed by the complainant.A further investigation revealed that the most likely point of entry of the fluid was through a small circular puncture in the air pouch of the icp probe.The icp probes are immediately sealed in the sterile barrier system following leakage testing during production.A dhr review confirms air-tightness at the final inspection of this probe.Hence, the most likely cause for the puncture in the air pouch which led to the malfunction is user mishandling of the probe prior to its application is mishandling by the health care professional.
Event or Problem Description
Spiegelberg received a complaint from a distributor "testing function before using, found error." for a type snd13.1.53 icp probe.

• Brand Name: SPIEGELBERG ICP PROBE
• Common Device Name: SPIEGELBERG ICP PROBE
• Manufacturer (Section D): SPIEGELBERG GMBH & CO. KG; tempowerkring 4; hamburg, 21079 ; GM 21079
• MDR Report Key: 6823354
• Report Number: 3002108226-2017-00013
• Device Sequence Number: 1197258
• Product Code: GWM
• Combination Product (Y/N): N
• PMA/510(K) Number: K003759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Type of Report: Initial
• Report Date (Section B): 08/27/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: SND13.1.53
• Device Catalogue Number: SND13.1.53/FV534P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1