MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH PHILIPS M2736A AVALON U/S TRANSDUCER

Model Number M2736A

Device Problems Crack (1135); Electrical Shorting (2926); Material Integrity Problem (2978); No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been received.The investigation is not yet complete.A follow-up report will be submitted upon completion of the device evaluation.

Event Description

Reportedly, post repair, the case was cracked.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection found the cable was broken.Technical visual inspection found the cable had a small kink around strain relief and the case was free of cosmetic and physical defects.Device evaluation identified failure of the ultrasound transducer electrical check.The cable assembly was replaced.All parameter tests were performed and passed.The cable, crystal, shake/rattle, and final visual inspections were all tested and passed as well.The root cause of the failed ultrasound transducer electrical check was determined to be a small kink around the strain relief of the cable.This type of event will continue to be monitored.Device code 1135 - removed.

• Brand Name: PHILIPS M2736A AVALON U/S TRANSDUCER
• Type of Device: TRANSDUCER
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH; hewlett-packard-str.-2; boeblingen, 71034 ; GM 71034
• MDR Report Key: 9210880
• MDR Text Key: 167627168
• Report Number: 3007409280-2019-00040
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2736A
• Device Catalogue Number: FFPH5505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1