MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION M SERIES; DEFIBRILLATOR/PACEMAKER

Model Number	MSERIES
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device inappropriately shut down.Complainant indicated that the patient sustained a serious injury.
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation; the device's battery pack was removed and returned.The reported malfunction was observed and attributed to battery capacity.The customer received a replacement battery pack.It is noteworthy to mention the m series operator's guide, page 11-3 under battery management states "carry a fully charged spare battery pack at all times".Communication from the customer indicated they did carry spare battery.The customer did confirm when a fully charged battery was installed, the device functioned.Analysis for reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device inappropriately shut down.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

• Brand Name: M SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 7126391
• Report Number: 1220908-2017-03158
• Device Sequence Number: 1210702
• Product Code: MKJ
• UDI-Device Identifier: 00847946016678
• UDI-Public: 00847946016678
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K972241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2017

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?: Yes
• Operator of Device: Other
• Device Model Number: MSERIES
• Device Catalogue Number: M SERIES
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other