MAUDE Adverse Event Report: ST PAUL PORTEX HYPERINFLATION RESUSCITATION MANOMETERS; MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR AL

Model Number	008201
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were ink stains on the surface of the devices.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#617147.No problem or issues were identified during the device history record review.No samples were received but two photos were received for evaluation.Based on the images provided, it was observed that there were ink stains inside tube, therefore failure mode can be confirmed.Root cause can be determined as operator mishandling using production equipment.A notification awareness to operators were issued in order to notify all personnel about issue reported with ink stains on manometer surface, a quality alert was implemented at manometer production line notifying about issue reported and a poka-yoke implementation in fixture at machine that will avoid starting the operation without adding a manometer tube.

• Brand Name: PORTEX HYPERINFLATION RESUSCITATION MANOMETERS
• Common Device Name: MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR AL
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12277180
• Report Number: 3012307300-2021-08062
• Device Sequence Number: 3112388
• Product Code: CAP
• UDI-Device Identifier: 10351688426352
• UDI-Public: 10351688426352
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2023

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 Model Number: 008201
• Device Catalogue Number: 008201
• Device Lot Number: 4079320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2021
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 05/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown