MAUDE Adverse Event Report: DRAEGER MEDICAL INFANT CARE, INC. RESUSCITAIRE WITH AUTOBREATH; INFANT RADIANT WARMER

Model Number	MU20503
Medical Device Problem Codes	Gas Output Problem (1266); Protective Measures Problem (3015)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 it was reported that while the customer was spot testing the peak inspiratory pressure of the resuscitation module (multiple devices, exact s/n not provided) with an analog manometer (customer's testing equipment) that they have observed a brief spike in pressure however the resuscitaire unit does not show a spike and does not climb past the set pressure.Note that the spot testing being performed is not a draeger test for the device.The customer has raised concerns that the potential spike (they have observed during their own testing) in pressure could potentially cause a pneumothorax in a patient.Currently the customer is not using the resuscitation module of the device while waiting on feedback from dräger.On 29apr2022 new information was received.The site respiratory therapist stated ¿that they do not get pneumos [pneumothorax, a collapsed lung] using the standalone blender¿.Though no specific patient details have been provided to date, this indicates an allegation that when the resuscitaire resuscitation module was used on patients, pneomos occur (patient injury).Additional information was requested regarding any events where a patient experienced a pneumothorax while the resuscitaire resuscitation module was being used.
Additional Manufacturer Narrative
Device mfr date: multiple units: (b)(4): 01/20/2021.(b)(4): 07/18/2018.(b)(4): 10/10/2011.(b)(4): 10/11/2011.A follow-up report will be submitted upon completion of this investigation.
Additional Manufacturer Narrative
Section h4 - multiple units: (b)(6): manufactured date 01/20/2021; (b)(6): manufactured date 07/18/2018; (b)(6): manufactured date 10/10/2011; (b)(6): manufactured date 10/11/2011.Further information regarding any patient events was requested however, no information has been provided to date.The manufacturer of the autobreath module (biomed devices) was consulted and it was confirmed that an initial spike is expected from the patient outlet output.This spike is mitigated by the resistance of the breathing tube and patient lung compliance.The circuit in the resuscitaire contains a pneumatic resistor to mimic the breathing tube and patient resistance so the manometer accurately represents what the lungs are receiving.The customer was provided a power point presentation showing test data of actual patient outlet output readings vs actual test lung input reading (what the patients lungs receive).The devices are working as designed, there was no device malfunction.
Event or Problem Description
On 25jan2022 it was reported that while the customer was spot testing the peak inspiratory pressure of the resuscitation module (multiple devices, exact s/n not provided) with an analog manometer (customer's testing equipment) that they have observed a brief spike in pressure however the resuscitaire unit does not show a spike and does not climb past the set pressure.Note that the spot testing being performed is not a draeger test for the device.The customer has raised concerns that the potential spike (they have observed during their own testing) in pressure could potentially cause a pneumothorax in a patient.Currently the customer is not using the resuscitation module of the device while waiting on feedback from dräger.On 29apr2022 new information was received.The site respiratory therapist stated ¿that they do not get pneumos [pneumothorax, a collapsed lung] using the standalone blender¿.Though no specific patient event information has been provided to date, this indicates an possible allegation that when the resuscitaire resuscitation module was used on patients, pneomos occur (potential patient injury).Additional information was requested regarding any events where a patient experienced a pneumothorax while the resuscitaire resuscitation module was being used.

• Brand Name: RESUSCITAIRE WITH AUTOBREATH
• Common Device Name: INFANT RADIANT WARMER
• Manufacturer (Section D): DRAEGER MEDICAL INFANT CARE, INC.; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL INFANT CARE, INC.; 3135 quarry road; telford PA
• MDR Report Key: 15288695
• Report Number: 2510954-2022-00004
• Device Sequence Number: 2468008
• Product Code: FMT
• UDI-Device Identifier: 04049098000215
• UDI-Public: (01)04049098000215(11)210125(93)MU20503-56
• Combination Product (Y/N): N
• PMA/510(K) Number: K120642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MU20503
• Device Catalogue Number: MU20503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 08/31/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown