MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SPO2 SENSOR SMALL ADULT/PEDIATRIC FINGER REUSABLE TRANSDUCER; SPO2/PLETH SENSOR

Model Number M1192A

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.The blister required incision and drainage along with antibiotics.It was also noted that the toe nail came off.Because medical intervention was required, we are considering this a serious injury.

Event Description

The customer stated that a patient was taken to picu after the cardiac surgery with spo2 probe m1192a attached.A nurse noticed that there was a blister on the toe of the baby's left foot.

Manufacturer Narrative

A return material authorization form was provided to the customer for the return of the product for evaluation.The customer provided photographs of both the sensor and the patient¿s toe however; the customer has not returned any product for evaluation.The customer feedback indicated that the surgery the patient underwent was going on for 6 to 7 hours.The customer also indicated that the sensor was not relocated during the surgery.This is contrary to the sensor¿s ifu (453564154671-l-ifu/a), which states that the sensor application site should be inspected every 2 to 3 hours and the that the sensor site should be moved every 4 hours or if circulation or skin integrity is compromised.Additionally, the m1192a sensor was attached to the patient¿s big toe during the surgery.Per the sensor¿s labeling (453564154671-l-ifu/a and 453564304981/b), the intended application site of the sensor is the patient¿s finger.It is not known how or if application of the sensor to the patient¿s big toe affects the performance of the sensor, but this is also a possible contributing factor to the incident.The product reportedly did not perform as expected by the customer.The investigation found that the sensor was used contrary to the sensor¿s labeling.The blister required incision and drainage, along with antibiotics.It was also noted that the toenail came off.There is no information to support that there was a product malfunction or defect that would have caused or contributed to the reported patient response.No additional investigation or action is warranted.We are considering that the product remains at the customer site.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: SPO2 SENSOR SMALL ADULT/PEDIATRIC FINGER REUSABLE TRANSDUCER
• Type of Device: SPO2/PLETH SENSOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8101402
• MDR Text Key: 128261930
• Report Number: 9610816-2018-00324
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M1192A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 MO
• Patient Weight: 5